High flow therapy device utilizing a non-sealing respiratory interface and related methods

ABSTRACT

A high flow therapy system for delivering heated and humidified respiratory gas to an airway of a patient, the system including a respiratory gas flow pathway for delivering the respiratory gas to the airway of the patient by way of a non-sealing respiratory interface; wherein flow rate of the pressurized respiratory gas is controlled by a microprocessor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/134,900, filed on Apr. 21, 2016, which is a continuation-inpart-application of U.S. patent application Ser. No. 14/016,042, filedon Aug. 30, 2013 which is a continuation application of U.S. patentapplication Ser. No. 11/999,675, filed on Dec. 6, 2007, which is nowU.S. Pat. No. 8,522,782 and issued Sep. 3, 2013, which is acontinuation-in-part application of U.S. patent application Ser. No.11/638,981, filed on Dec. 14, 2006, which is now U.S. Pat. No. 8,333,194and issued Dec. 18, 2012, which is a continuation-in-part application ofU.S. patent application Ser. No. 11/520,490, filed on Sep. 12, 2006,which claims the benefit of U.S. Provisional Patent Application Ser. No.60/716,776, filed Sep. 12, 2005. U.S. patent application Ser. No.11/638,981 also claims the benefit and priority of U.S. ProvisionalPatent Application Ser. No. 60/750,063, filed on Dec. 14, 2005; U.S.Provisional Patent Application Ser. No. 60/792,711, filed on Apr. 18,2006; and U.S. Provisional Patent Application Ser. No. 60/852,851, filedon Oct. 18, 2006. The entire contents of each of these applications arehereby incorporated by reference herein.

BACKGROUND

In respiratory medicine, ventilation devices are typically used todeliver respiratory gases for therapeutic effect. Ventilators have beenused with invasive patient interface, such as endotracheal tubes.Bi-level, Bi-PAP, and CPAP devices have been used with non-invasivepatient interfaces, such as respiratory masks. When an option,non-invasive respiratory systems are preferred for increased patientcomfort and reduced risks. Non-invasive ventilation (NIV) systems suchas Bi-Level PAP (positive airway pressure) require the use of a sealedpatient interface, such as a full face mask. Systems with patientinterface that seal on the patient (i.e. closed systems) can generatehigher pressures with low flows or non-continuous flows. Sealed patientinterfaces are not as comfortable or easy to apply as non-sealed patientinterface, such as nasal cannulas. However, non-sealing nasal cannulasdo not work properly with NIV systems. Nasal cannulas are typically usedwith basic oxygen delivery systems that have flow limitations forvarious reasons. There is a need for a respiratory gas delivery systemthat works optimally with non-sealing patient interfaces to producetherapeutic effects to the patient similar to that of NIV systems.Because the system has a non-sealing patient interface and thereforesome gas and pressure is lost to atmosphere, this respiratory gasdelivery system must be able to deliver gas at high flows that are highenough to generate positive pressure in the patient's airway.

Respiratory interfaces, e.g., nasal cannulas are used to deliverrespiratory gases for therapeutic effect, including oxygen therapy,treatment for sleep apnea, and respiratory support. Small nasal cannulasare commonly used for delivery of low volumes of oxygen. Sealing nasalcannulas, such as the cannulas disclosed in U.S. Pat. No. 6,595,215 toWood, are used for the treatment of sleep apnea. However, treatment withcertain types of nasal cannulas may be limited by the lack ofinformation available on important treatment parameters. Theseparameters include information regarding the gases within the user'supper airway, such as pressure, flow rate, and carbon dioxide buildup.These and other data may be useful in judging the efficacy of treatmentas well as for controlling and monitoring treatment.

In addition, prior art nasal cannula designs (especially those designedfor neonatal oxygen therapy) may undesirably create a seal with theuser's nares, which may have detrimental effects on the user's health.

Oxygen (O₂) therapy is often used to assist and supplement patients whohave respiratory impairments that respond to supplemental oxygen forrecovery, healing and also to sustain daily activity.

Nasal cannulas are generally used during oxygen therapy. This method oftherapy typically provides an air/gas mixture including about 24% toabout 35% O₂ at flow rates of 1-6 liters per minute (L/min). At aroundtwo liters per minute, the patient will have an FiO₂ (percent oxygen inthe inhaled O₂/air mixture) of about 28% oxygen. This rate may beincrease somewhat to about 8 L/min if the gas is passed through ahumidifier at room temperature via a nasal interface into the patient'snose. This is generally adequate for many people whose conditionresponds to about 35-40% inhaled O₂ (FiO₂), but for higherconcentrations of O₂, higher flow rates are generally needed.

When a higher FiO₂ is needed, one cannot simply increase the flow rate.This is true because breathing 100% O₂ at room temperature via a nasalcannula is irritating to the nasal passage and is generally nottolerated above about 7-8 L/min. Simply increasing the flow rate mayalso provoke bronchospasm.

To administer FiO₂ of about 40% to about 100%, non-re-breathing masks(or sealed masks) are used at higher flows. The mask seals on the faceand has a reservoir bag to collect the flow of oxygen during theexhalation phase and utilize one-way directional valves to directexhalation out into the room and inhalation from the oxygen reservoirbag. This method is mostly employed in emergency situations and isgenerally not tolerated well for extended therapy.

High flow nasal airway respiratory support (“high flow therapy” or“HFT”) is administered through a nasal cannula into an “open” nasalairway. The airway pressures are generally lower than ContinuousPositive Airway Pressure (CPAP) and Bi-level Positive Airway Pressure(BiPAP) and are not monitored or controlled. The effects of such highflow therapies are reported as therapeutic and embraced by someclinicians while questioned by others because it involves unknownfactors and arbitrary administration techniques. In such procedures, thepressures generated in the patients' airways are typically variable,affected by cannula size, nare size, flow rate, and breathing rate, forinstance. It is generally known that airway pressures affect oxygensaturation, thus these variables are enough to keep many physicians fromutilizing HFT.

SUMMARY

The present disclosure relates to a gas delivery conduit adapted forfluidly connecting to a respiratory gases delivery system in a high flowtherapy system. In one embodiment, the gas delivery conduit includes afirst connector adapted for connecting to the respiratory gases deliverysystem, a second connector adapted for connecting to a fitting of apatient interface and tubing fluidly connecting the first connector tothe second connector where the first connector has a gas inlet adaptedto receive the supplied respiratory gas. In one aspect of thisembodiment, the gas delivery conduit includes one of electrical contactsand temperature contacts integrated into the first connector. In anotheraspect of this embodiment, the gas delivery conduit includes a sensingconduit integrated into the gas delivery conduit. In yet another aspectof this embodiment, the first connector of the gas delivery conduit isadapted to allow the user to couple the first connector with therespiratory gases delivery system in a single motion. In yet anotheraspect of this embodiment, the first connector of the gas deliveryconduit is adapted to allow the user to couple the first connector withthe respiratory gases delivery system by moving the connector in adirection along an axis of the gas inlet.

The present disclosure relates to a high flow therapy system including amicroprocessor, one or more heating elements, a non-sealing respiratoryinterface and a sensor. The heating elements are disposed in electricalcommunication with the microprocessor and are capable of heating aliquid to create a gas. The non-sealing respiratory interface isconfigured to deliver the gas to a patient. The sensor is disposed inelectrical communication with the microprocessor and is configured tomeasure pressure in an upper airway of the patient.

The present disclosure also relates to a method of supplying a patientwith gas. The method includes providing a high flow therapy deviceincluding a microprocessor, one or more heating elements disposed inelectrical communication with the microprocessor and capable of heatinga liquid to create a gas, a non-sealing respiratory interface configuredto deliver the gas to a patient and a sensor disposed in electricalcommunication with the microprocessor and configured to measure pressurein the upper airway of the patient. This method also includes heatingthe gas and delivering the gas to a patient.

The present disclosure also relates to a method of minimizingrespiratory infections of a patient. The method includes providing ahigh flow therapy device, heating the gas and delivering the gas to apatient. The high flow therapy device of this method includes at leastone heating element capable of heating a liquid to create a gas and anon-sealing respiratory interface configured to deliver the gas to apatient.

The present disclosure also relates to a method of supplying a patientwith gas. The method including providing a high flow therapy device,heating a gas and delivering the gas to a patient. The high flow therapydevice of this method includes at least one heating element, anon-sealing respiratory interface, a blower, an air inlet port and anair filter. The at least one heating element is capable of heating aliquid to create a gas. The non-sealing respiratory interface isconfigured to deliver the gas to a patient. The blower is disposed inmechanical cooperation with the non-sealing respiratory interface and iscapable of advancing the gas at least partially through the non-sealingrespiratory interface. The air inlet port is configured to enableambient air to flow towards to the blower. The air filter is disposed inmechanical cooperation with the air inlet port and is configured toremove particulates from the ambient air.

The present disclosure also relates to a method of supplying a patientwith gas. The method includes providing a high flow therapy device,heating a gas and delivering the gas to a patient. The high flow therapydevice of this method includes at least one heating element, anon-sealing respiratory interface, and controlling a source of one ormore compressed gases. The at least one heating element is capable ofheating a liquid to create a gas. The non-sealing respiratory interfaceis configured to deliver the gas to a patient. The compressed gascontrol mechanism is disposed in mechanical cooperation with thenon-sealing respiratory interface and is capable of advancing the gas atleast partially through the non-sealing respiratory interface.

The present disclosure also relates to a method of treating a patientfor an ailment such as a headache, upper airway resistance syndrome,obstructive sleep apnea, hypopnea and snoring. The method includesproviding a high flow therapy device, heating a gas and delivering thegas to a patient. The high flow therapy device includes at least oneheating element capable of heating a liquid to create a gas and anon-sealing respiratory interface configured to deliver the gas to apatient.

The present disclosure also relates to a method of deliveringrespiratory gas to a patient. The method includes providing a high flowtherapy device, monitoring the respiratory phase of the patient andpressurizing the gas. The high flow therapy device of this methodincludes at least one heating element capable of heating a liquid tocreate a gas, a non-sealing respiratory interface configured to deliverthe gas to a patient, and a sensor configured to measure pressure in theupper airway of the patient.

The present disclosure also relates to a high flow therapy deviceincluding a microprocessor, at least one heating element, a non-sealingrespiratory interface, a sensor and a mouthpiece. The at least oneheating element is disposed in electrical communication with themicroprocessor and is capable of heating a liquid to create a gas. Thenon-sealing respiratory interface is configured to deliver the gas to apatient. The sensor is disposed in electrical communication with themicroprocessor and is configured to measure pressure in an upper airwayof the patient. The mouthpiece is disposed in mechanical cooperationwith the sensor.

BRIEF DESCRIPTION OF THE DRAWINGS

Reference will now be made to the accompanying drawing figures, whichare not necessarily drawn to scale.

FIG. 1 is a perspective view of a nasal cannula according to aparticular embodiment of the invention.

FIG. 2 is a perspective view of a nasal cannula according to a furtherembodiment of the invention.

FIG. 3 is a perspective view of a nasal cannula according to anotherembodiment of the invention.

FIG. 4 is a perspective view of a nasal cannula according to yet anotherembodiment of the invention.

FIG. 5 is a front perspective view of a nasal cannula according to afurther embodiment of the invention.

FIG. 6 depicts a cross section of a nasal insert of a nasal cannulaaccording to a particular embodiment of the invention.

FIG. 7 depicts a cross section of a nasal insert of a nasal cannulaaccording to a further embodiment of the invention.

FIG. 8A is a front perspective view of a nasal cannula according toanother embodiment of the invention.

FIG. 8B is a rear perspective view of the nasal cannula shown in FIG.8A.

FIG. 8C is a perspective cross-sectional view of the nasal cannula shownin FIG. 8A.

FIG. 9 is a perspective view of a nasal cannula according to a furtherembodiment of the invention.

FIG. 10 is a perspective view of a nasal cannula according to anotherembodiment of the invention.

FIG. 11 is a perspective view of a nasal cannula according to a furtherembodiment of the invention.

FIG. 12 is a perspective view of a nasal cannula according to yetanother embodiment of the invention.

FIG. 13 illustrates an embodiment of a nasal cannula in use on apatient, according to one embodiment of the invention.

FIG. 14 illustrates another embodiment of a nasal cannula in use on apatient, according to a further embodiment of the invention.

FIG. 15 illustrates a perspective view of a high flow therapy device inaccordance with an embodiment of the present disclosure.

FIG. 16 illustrates a perspective view of the high flow therapy deviceof FIG. 15 showing internal components, in accordance with an embodimentof the present disclosure.

FIGS. 17 and 17A illustrates a schematic view of the high flow therapydevice of FIGS. 15 and 16 with a nasal interface and a patient inaccordance with embodiments of the present disclosure.

FIG. 18 illustrates a high flow therapy device including a nasalinterface and a conduit in accordance with an embodiment of the presentdisclosure.

FIGS. 19 and 20 illustrate an enlarged view of a patient's upper airwayand a nasal interface in accordance with two embodiments of the presentdisclosure.

FIG. 21 illustrates an example of a screen shot of a user interface ofthe high flow therapy device of FIGS. 15-17 in accordance with anembodiment of the present disclosure.

FIGS. 22 and 23 illustrate examples of a non-sealing respiratoryinterface in the form of a mouthpiece in accordance with embodiments ofthe present disclosure.

FIG. 24 illustrates a mouthpiece of FIG. 22 or 23 in use on a patient inaccordance with an embodiment of the present disclosure.

FIG. 25 illustrates an enlarged view of a connector according to anembodiment of the present disclosure.25.

FIG. 26 illustrates a perspective view of a therapy device and theconnector of FIG.

FIG. 27 illustrates a longitudinal cross-sectional view of the connectorof FIG. 25

FIG. 28 illustrates a top view of the therapy device of FIG. 26 havingthe connector operably coupled to the therapy device.

FIG. 29 is a transverse cross-sectional view of a humidity chamber of atherapy device according to an embodiment of the present disclosure.

FIGS. 29A-29C are an enlarged sectional views of a portion of thehumidity chamber according to embodiments of the present disclosure.

FIG. 30 is a perspective view of a connector according to an embodimentof the present disclosure.

FIG. 31 is a longitudinal cross-sectional view of the connector of FIG.30.

FIGS. 32A and 32B are schematic illustrations of the flow of gasaccording to embodiments of the present disclosure.

FIGS. 33A-33C show various aspects of a humidity chamber in accordancewith embodiments of the present disclosure.

FIGS. 34A-34D illustrate a saddle for use with a therapy device of thepresent disclosure.

FIG. 35 illustrates a patient with a nasal cannula and an ear lobeprobe.

FIG. 36 illustrates a perspective view of a high flow therapy systempositioned on a cart in accordance with an embodiment of the presentdisclosure.

FIG. 37 illustrates an exploded view of the high flow therapy system ofFIG. 36 illustrating the major components in a disassembledrelationship. in accordance with an embodiment of the presentdisclosure.

FIG. 38 illustrates an assembled view of the high flow therapy system ofFIG. 36 illustrating the major components in an assembled relationship,in accordance with an embodiment of the present disclosure.

FIG. 39 illustrates a schematic view of the high flow therapy system ofFIG. 36 in accordance with an embodiment of the present disclosure.

FIG. 40 illustrates a top perspective view of the high flow therapydevice of FIG. 36 showing internal components with the upper enclosureremoved, in accordance with an embodiment of the present disclosure.

FIG. 41 illustrates a rear perspective view of the high flow therapydevice of FIG. 36 showing internal components with the upper enclosureremoved, in accordance with an embodiment of the present disclosure.

FIG. 42 illustrates a top view of the high flow therapy device of FIG.36 showing internal components with the upper enclosure removed, theheater plate removed, and the outlet adapter shown transparent, inaccordance with an embodiment of the present disclosure.

FIG. 43 illustrates a receiving area for a first connector of a deliverycircuit according to an embodiment of the present disclosure.

FIG. 44 illustrates the first connector of the delivery circuitaccording to an embodiment of the present disclosure.

FIG. 45 illustrates a perspective sectional view of the first connectorend of the delivery circuit according to an embodiment of the presentdisclosure.

FIG. 46 illustrates a first perspective sectional view of a secondconnector the delivery circuit and patient fitting of the patientinterface according to an embodiment of the present disclosure.

FIG. 47 illustrates a second perspective sectional view of a secondconnector the delivery circuit and patient fitting of the patientinterface according to an embodiment of the present disclosure.

FIG. 48 illustrates a perspective sectional view of the delivery circuitat the second connector end with the second connector and sensingconduit removed. according to an embodiment of the present disclosure.

FIG. 49 illustrates the patient interface according to an embodiment ofthe present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

The present inventions now will be described with reference to theaccompanying drawings, in which some, but not all embodiments of theinventions are shown. Indeed, these inventions may be embodied in manydifferent forms and should not be construed as limited to theembodiments set forth herein. Rather, these embodiments are provided sothat this disclosure will satisfy applicable legal requirements. Likenumbers refer to like elements throughout. For example, elements 130,230, 330, 430, 530, 830, and 930 are all nasal inserts according tovarious embodiments of the invention.

Overview of Functionality

Nasal cannula according to various embodiments of the invention may beconfigured to deliver high-flow therapeutic gases to a patient's upperairway through the patient's nose. Such gases may include, for example,air, humidity, oxygen, therapeutic gases or a mixture of these, and maybe heated or unheated. In particular embodiments of the invention, thecannula may be useful for CPAP (continuous positive airway pressure)applications, which may be useful in the treatment of sleep apnea and inproviding respiratory support to patients (e.g., after abdominalsurgery), to alleviate snoring, or for other therapeutic uses.

Nasal cannula according to particular embodiments of the inventioninclude (or are adapted to facilitate the positioning of) one or moresensors adjacent or within one or more of the cannula's nasal inserts.Accordingly, the nasal cannula may be configured so that at least aportion of one or more sensors is in place in one or both of a user'snares when the nasal cannula is operably worn by the user. This may beparticularly helpful in evaluating the environment of the internalportion of the user's nose and/or the user's upper airway. As describedin greater detail below, in various embodiments of the invention, thecannula is adapted so that it will not create a seal with the patient'snares when the cannula is in use.

Nasal cannula according to other embodiments of the invention includenozzles that are adapted to remain outside of a user's nares while thecannula is in use. Accordingly, the nozzles avoid sealing with thepatient's nares while the cannula is in use. In some embodiments, thenasal cannula include elongate extensions that are inserted into theuser's nares to detect pressure in one or both nares.

In certain embodiments of the invention, sensors are provided adjacentor within both of the nasal cannula's nasal inserts. In various otherembodiments, sensors are provided adjacent or within one or moreelongate extensions that extend into the user's nares. In variousembodiments, elongate extensions may be used in conjunction with nasalinserts or with nozzles. The use of sensors may be useful, for example,in monitoring environmental changes from one of the user's nares to theother. This information may be helpful, for example, in determining whenthe dominant flow of air changes from one of the user's nares to theother, which may affect the desired flow characteristics of therapy.Accordingly, data from each nare may provide information that may beuseful in establishing or modifying the user's treatment regimen.Further, multiple sensors may be used in various embodiments.

Overview of Exemplary Cannula Structures

A cannula 10 according to one embodiment of the invention is shown inFIG. 1. As may be understood from this figure, in this embodiment, thecannula 10 includes a base portion 105, which is hollow, elongated, andtubular that includes a central portion 110, a first end portion 115,and a second end portion 120. The first and second end portions 115, 120may be angled relative to the central portion 110 as shown in FIG. 1.

In various embodiments of the invention, the cannula 10 includes a firstinlet 117 adjacent the outer end of the first end portion 115, and asecond inlet 122 adjacent the second end portion 120 (in otherembodiments, the cannula may include only one such inlet). The cannula10 further comprises a pair of hollow, elongated, tubular nasal inserts(e.g., nasal catheters), nasal inserts 125, 130.1 that extend outwardlyfrom the base portion 105 and that are in gaseous communication with thebase portion's interior. In various embodiments, the respective centralaxes of the nasal inserts 125, 130 are substantially parallel to eachother, and are substantially perpendicular to the central axis of thecentral portion 110 of the base portion 105.

In particular embodiments of the invention, the cannula defines at leastone conduit that is adapted to guide at least one sensor so that thesensor is introduced adjacent or into the interior of the cannula sothat, when the cannula is being operably worn by a user, the environmentbeing monitored by the at least one sensor reflects that of the internalportion of the user's nose and/or the user's upper airway. In variousembodiments of the invention, a user may temporarily insert the at leastone sensor into or through the conduit to determine correct settings forthe cannula system, and then may remove the sensor after the correctsettings have been achieved. In other embodiments, the at least onesensor may be left in place within the conduit for the purpose ofmonitoring data within (or adjacent) the cannula over time (e.g., forpurposes of controlling the user's therapy regimen). In a furtherembodiment, the at least one sensor may be positioned adjacent an outletof the conduit.

The at least one sensor may be connected (e.g., via electrical wires) toa computer and/or a microprocessor that is controlling the flow ofrespiratory gases into the cannula. The computer may use informationreceived from the at least one sensor to control this flow of gas and/orother properties of the system, or may issue an alarm if the informationsatisfies pre-determined criteria (e.g., if the information indicatespotentially dangerous conditions within the patient's airway or if thesystem fails to operate correctly).

As may be understood from FIGS. 8A-8C, in a particular embodiment of theinvention, at least one of the cannula's conduits 850 is defined by, andextends within, a side wall of the cannula 800. Alternatively, theconduit may be disposed within an interior passage defined by thecannula. For example, one or more of the conduits may be defined by atube that is attached immediately adjacent an interior surface of thecannula (e.g., adjacent an interior surface of the cannula's baseportion, or an interior surface of one of the cannula's nasal inserts).The cannula's conduits are preferably adapted for: (1) receiving a flowof gas at one or more inlets that are in communication with the conduit,and (2) guiding this flow of gas to an outlet in the cannula. In variousembodiments, one or more of the inlets is defined within an exteriorportion of one of the cannula's nasal inserts.

As may be understood from FIG. 1, in various embodiments of theinvention, each of the cannula's conduit outlets 136, 141 is located atthe end of a respective elongate, substantially tubular, outlet member135, 140. For example, in the embodiment shown in FIG. 1, the cannula 10includes a first outlet member 135 that is substantially parallel to thecannula's first nozzle 125. In this embodiment, the first outlet member135 and the first nozzle 125 may be positioned on opposite sides of thenasal cannula's base portion 105 as shown in FIG. 1. Similarly, in aparticular embodiment of the invention, the cannula 10 includes a secondoutlet member 140 that is substantially parallel to the cannula's secondnasal insert 130. The second outlet member 140 and second nozzle 130 arealso preferably positioned on opposite sides of the base portion 105.Nozzles 125, 130 also may have nozzle outlets 181, 182 respectively.

In various embodiments of the invention, a sensor (e.g., a pressure,temperature, or O₂ sensor) is provided adjacent at least one of (andpreferably each of) the cannula's outlets 136, 141 and is used tomeasure the properties of gas from that outlet 136, 141. In a furtherembodiment of the invention, accessory tubing is used to connect eachoutlet 135, 140 with at least one corresponding sensor (and/or at leastone external monitoring device) that may, for example, be spaced apartfrom the cannula 10.

In yet another embodiment of the invention, one or more sensors areprovided within the conduit, and used to measure the properties of gasaccessed through the conduit. In this embodiment, information from eachsensor may be relayed to a control system outside the cannula via, forexample, an electrical wire that extends from the sensor and through theoutlet 135, 140 of the conduit in which the sensor is disposed.

In alternative embodiments of the invention, each of the cannula'sconduits may extend: (1) from the inlets 152, 154; (2) through, oradjacent, a side wall of one of the nasal inserts 125, 130; (3) through,or adjacent, a side wall of the body portion 105; and (4) to an outlet135, 140 that is defined within, or disposed adjacent, the body portion105. In one such embodiment, the conduit comprises a substantiallytubular portion that is disposed adjacent an interior surface of thecannula's body portion.

As may be understood from FIG. 2, in certain embodiments of theinvention, the cannula 200 includes at least one sensor 245 that isintegrated into an exterior portion of the cannula 200 (e.g., within arecess 223 formed within an exterior surface of one of the cannula'snasal inserts, nasal inserts 225, 230). In this embodiment, informationfrom the sensor 245 may be relayed to a control system outside thecannula 200 via an electrical wire 246 that extends from the sensor 245,through a conduit, and out an outlet 235, 240 in the conduit. In variousembodiments of the invention, the conduit extends through or adjacent aninterior portion of a sidewall of one of the nasal inserts 225, 230and/or through or adjacent an interior portion of a sidewall of the bodyportion 205. Nozzles 225, 230 also have nozzle outlets 281,282respectively.

In particular embodiments of the invention, at least one sensor 245 isfixedly attached to the cannula 10 so that it may not be easily removedby a user. Also, in particular embodiments, at least one sensor 245 isdetachably connected adjacent the cannula 10 so that the sensor 245 maybe easily detached from (and, in certain embodiments, reattached to) thecannula 10.

The cannula 1000 includes a base portion 1005, which is hollow,elongated, and tubular, that includes a central portion 1010, a firstend portion 1015, and a second end portion 1020. The first and secondend portions 1015 and 1020 may be angled relative to the central portion1010, as shown in FIG. 10. In various embodiments of the invention, thecannula 1000 includes a first tubing inlet 1017 adjacent the outer endof the first end portion 1015, and a second tubing inlet 1022 adjacentthe outer end of the second end portion 1020.

The cannula 1000 further comprises a pair of hollow, elongated, tubularnozzles (a first nozzle 1026 and a second nozzle 1031) that extendoutwardly from the base portion 1005. In various embodiments, therespective central axes of the nozzles 1026, 1031 are substantiallyparallel to each other and are substantially perpendicular to thecentral axis of the central portion 1010 of the base portion 1005. Invarious embodiments, the nozzles 1026, 1031 define conduits that are ingaseous communication with the interior of the base portion 1005. Inparticular embodiments of the invention, the first and second nozzles1026, 1031 are adapted to be positioned outside of a user's nares whilethe cannula is in use. In particular embodiments, the nozzles 1026, 1031each define a respective nozzle outlet. For example, the first nozzle1026 defines a first nozzle outlet 1083, and the second nozzle 1031defines a second nozzle outlet 1084. In various embodiments, when thecannula 1000 is operatively positioned adjacent a user's nares, each ofthe nozzle's outlets 1083, 1084 is positioned to direct a focused flowof gas into a corresponding one of the user's nares.

In alternative embodiments, such as the embodiment shown in FIG. 12, thecannula 1200 may include a single nozzle 1227 that defines a conduit orair passageway that is in gaseous communication with an interior portionof the base portion 1205. As described in greater detail below, invarious embodiments, the nozzle 1227 extends outwardly from the baseportion 1205 and has an oblong, or elliptical, cross-section. In thisand other embodiments, the nozzle 1227 is shaped to deliver a focusedflow of gas simultaneously into both of a user's nares when the cannula1200 is in use.

In various embodiments, the nasal cannula includes one or more elongateextensions that are adapted for insertion into one or more of the user'snares. For example, returning to the embodiment shown in FIG. 10, thecannula 1000 may include multiple elongate extensions (for example afirst elongate extension 1070 and a second elongate extension 1072) thatare long enough to allow each of the elongate extensions 1070, 1702 tobe inserted into a respective one of the user's nares while the cannula1000 is in use. In embodiments, elongate extensions 1070, 1072 may haveconduit inlets 1052, 1053 respectively. In various embodiments, each ofthe elongate extensions 1070, 1072 may have a central axis that runssubstantially parallel to the central axis of a corresponding nozzle1026, 1031. For example, as can be understood from FIG. 10, in certainembodiments, a first elongate extension 1070 has a central axis thatlies substantially parallel to and below the central axis of acorresponding first nozzle 1026, when the cannula is operativelypositioned adjacent a user's nares. Similarly, in various embodiments, asecond elongate extension 1072 has a central axis that liessubstantially parallel to and below the central axis of a correspondingsecond nozzle 1031, when the H-aSal cannula 1000 is operativelypositioned adjacent a user's nares. In various other embodiments, theelongate extensions may lie within, and extend outwardly from, theircorresponding nozzles 1070, 1072.

As a further example, FIG. 12 illustrates an exemplary cannula 1200having multiple elongate extensions (a first elongate extension 1270 anda second elongate extension 1272), which both lie substantially beyond asingle nozzle 1227 when the cannula 1200 is in an operative positionadjacent the user's nose. In some embodiments, the central axes of thefirst and second elongate extensions 1270, 1272, may be substantiallyparallel to the central axis of the nozzle 1227. Also, in variousembodiments, one or both of the elongate extensions 1270, 1272 may liewithin the nozzle 1227. In this and other embodiments, a distal end ofeach of the elongate extensions 1270, 1272 may extend beyond a distalend of the nozzle 1227. Elongate extensions 1270, 1272 may have conduitinlets 1252, 1253 respectively, while nozzle 1227 has a nozzle outlet1281.

As described above, in certain embodiments of the invention, the nasalcannula includes one or more sensors that are adapted to measure gasdata (e.g., gas pressure) within the user's nares while the cannula isin use. For example, the cannula 1000 shown in FIG. 10 may include asensor positioned adjacent the distal end of one or both of the firstand second elongate extensions 1070, 1072. In various embodiments, eachelongate extension may be adapted to: (1) support a sensor adjacent(e.g., at) the distal end of the elongate extension; and (2) support awire that is simultaneously connected to the sensor and a controlmechanism that is adapted to adjust the properties of gas flowingthrough the cannula 1000.

In other embodiments, the elongate extensions define conduits. Forexample, one or more sensor(s) may be positioned within the interior orexterior of the elongate extensions and information from the sensor(s)may be relayed to a control system via a wire extending through aconduit (for example, elongate extension conduit 1023 of FIG. 10) orpassages defined by each of the elongate extensions. In one embodiment,as shown, for example, in FIG. 10, the elongate extension conduit 1023is shaped similarly to the base portion 1005, and lies substantiallybelow the base portion 1005 when the cannula 1000 is operatively in use.In various embodiments, the elongate extension conduit 1023 ispositioned within the base portion 1005 such that the first and secondelongate extensions 1070, 1072 lie within, and extend outwardly from,the respective first and second nozzles 1026, 1031.

In various embodiments, each elongate extension defines a respectiveconduit that can serve as an air passageway. For example, in certainembodiments, each conduit is adapted to provide a passage that permitsgaseous communication between a user's nares and a control system orother device for measuring and adjusting the properties of the air. Inthis and other embodiments, a sensor may be positioned at the controlbox to measure the properties (e.g., pressure) of air in the user'snares. In some embodiments, the elongate extensions define a conduitthat serves both as an air passageway as well as a conduit for allowinga wire to pass from a sensor positioned adjacent the tip of the elongateextension to the control system or other device.

Data Monitored by Sensors

In various embodiments of the invention, such as those described above,one or more sensors may be positioned to measure gas data within aninterior portion of one of the nasal cannula's conduits, or to measuregas data adjacent an exterior portion of the cannula. In suchembodiments, one or more sensors may be, for example, positionedadjacent an interior or exterior surface of the cannula. In certainembodiments of the invention, one or more of the cannula's sensors isadapted to monitor one or more of the following types of data within thecannula's conduits, or adjacent the cannula's exterior surface (e.g.,adjacent a side portion, or distal end of, one of the cannula's nasalinserts): (1) gas pressure; (2) gas flow rate; (3) carbon dioxidecontent; (4) temperature; (5) level; and/or (6) oxygen content.

Absolute vs. Relative Pressure Measurements

In various embodiments of the invention, the cannula may be configuredfor sensing absolute pressure within, or adjacent, a particular portionof the cannula. Similarly, in particular embodiments, the cannula may beconfigured to measure the difference between the pressure at twodifferent locations within the cannula. This may be done, for example,by providing two separate sensors (e.g., that are positioned indifferent locations within one of the cannula's conduits), or byproviding two physically distinct gas intake conduits, each of which isadapted for routing gas from a different location within the cannula.For example, in various embodiments of the invention shown in FIG. 1,the first inlet 152 may be connected to a first intake conduit that isadapted for routing gas to a first sensor, and the second inlet 154 maybe connected to a physically separate second intake conduit that isadapted for routing gas to a second pressure sensor. Information fromthe first and second sensors may then be used to calculate thedifference in pressure between the first and second inlets 152, 154.Alternatively, a differential pressure sensor may be used.

Suitable Sensors

Suitable sensors for use with various embodiments of the inventioninclude electronic and optical sensors. For example, suitable sensorsmay include: (1) Disposable MEM Piezoelectric sensors (e.g., from SilexMicrosensors); (2) light-based sensors such as a McCaul O₂ sensor—seeU.S. Pat. No. 6,150,661 to McCaul; and (3) Micro-pressure sensors, suchas those currently available from Honeywell.

Non-Sealing Feature

As shown in FIG. 4, in various embodiments of the invention, cannula 400has one or more nasal inserts 425, 430 that defines one or more recesses423 (e.g., grooves, semicircular recesses, or other indentations orconduits) that extend along a length of the nasal insert's exteriorsurface. As may be understood from this figure, in various embodimentsof the invention, at least one of these recesses 423 is an elongategroove that extends from adjacent a distal surface of the nasal insert325, 330, 425, 430 and past the midpoint between: (1) the nasal insert'sdistal surface and (2) the portion of the nasal insert 425, 430 that isimmediately adjacent the nasal cannula's base portion 305, 405. As mayalso be understood from this figure, in various embodiments of theinvention, each groove 423 extends substantially parallel to the centralaxis of its respective nasal insert 425, 430.

In particular embodiments of the invention, such as the embodiment shownin FIG. 4, at least one of the nasal inserts 425, 430 is configured sothat when the nasal inserts 425, 430 are operatively positioned within auser's nares, the nasal inserts do not form an airtight seal with theuser's nares. This may be due, for example, to the ability of air toflow adjacent the user's nare through recesses 423 in the nozzles 425,430 when the user is wearing the nasal cannula.

FIGS. 5-8 depict additional embodiments of the invention that areconfigured so that when the cannula's nasal inserts are operativelypositioned adjacent (e.g., partially within) the user's nares, the nasalinserts do not form a seal with the user's nares. For example, in theembodiment shown in FIG. 5, FIG. 5, illustrating cannula 500, at leastone (and preferably both) of the cannula's nasal inserts, nasal inserts525, 530, comprise a nasal insert body portion 555 (which may, forexample, be substantially tubular), and one or more flange portions,flanges 560, 561, that are adapted to maintain a physical separationbetween an exterior side surface of the nasal insert body portion 555and a user's nare when the nasal insert 525, 530 is inserted into theuser's nare.

For example, in the embodiment of the invention shown in FIG. 5, each ofthe nasal inserts 525, 530 includes a 555 and a pair of co-facing,elongated flanges, flanges 560, 561, that each have a substantiallyC-shaped cross section. In this embodiment, these flanges 560, 561cooperate with a portion of the exterior of the inlet 555 to form asubstantially U-shaped channel (which is one example of a “nasal lumen”)through which ambient air may flow to and/or from a user's nasalpassages when the cannula 500 is operatively in place within the user'snares. In this embodiment, when the nasal inserts 525, 530 are properlyin place within the user's nares, respiratory gas is free to flow intothe user's nose through the inlet 555, and ambient air is free to flowinto and out of the user's nose through a passage defined by: (1) theflanges 560, 561; (2) the exterior side surface of the inlet 555 thatextends between the flanges 560, 561; and (3) an interior portion of theuser's nose. In various embodiments, air may flow to and/or from auser's nose through this passage when the cannula 500 is operatively inplace within the user's nares. A pathway (e.g., a semicircular pathway)may be provided adjacent the interior end of this U-shaped channel,which may act as a passageway for gas exhaled and inhaled through theU-shaped channel.

The general embodiment shown in FIG. 5 may have many differentstructural configurations. For example, as shown in FIG. 6, whichdepicts a cross section of a nasal insert according to a particularembodiment of the invention, the respiratory gas passageways of thenasal inserts 655 of a cannula may be in the form of a tube having anirregular cross section (e.g., a substantially pie-piece-shaped crosssection) rather than a circular cross section. Alternatively, as may beunderstood from FIG. 7, the respiratory gas passageways of the s nasalinserts 755 of a cannula may be in the form of a tube having asubstantially half-circular cross section rather than a circular crosssection.

Similarly, as may be understood from FIGS. 6 and 7, the shape and sizeof the cannula's flanges may vary from embodiment to embodiment. Forexample, in the embodiment shown in FIG. 6, each of the flanges 660, 661has a relatively short, substantially C-shaped cross section and thedistal ends of flanges 660, 661 are spaced apart from each other to forma gap. As shown in FIG. 7, in other embodiments, each of the flanges760, 761 may have a relatively long, substantially C-shaped crosssection and the distal ends of the flanges 760, 761 may be positionedimmediately adjacent each other.

As may be understood from FIG. 7, in various embodiments of theinvention, a separation 763 (e.g., a slit, such as an angular slit) isprovided between the flanges 760, 761. This may allow the flanges 760,761 to move relative to each other and to thereby conform to the nare inwhich the nasal insert is inserted. In other embodiments, the crosssection of the nasal inserts is substantially as that shown in FIG. 7,except that no separation 763 is provided within the semi-circularflange portion. Accordingly, in this embodiment of the invention, asubstantially semi-circular portion of the exterior of the air inletcooperates with a substantially semi-circular portion of the flangeportion to form an exterior having a contiguous, substantially circularcross section. One such embodiment is shown in FIGS. 8A-8C.

As may be understood from FIGS. 8A-8C, in this embodiment, when thecannula 800 is in use, respiratory gas may flow into the user's nosethrough passageways 881 (e.g., a portion of which may be defined by acorresponding respiratory gas inlet 855) that extend through each of thecannula's nasal inserts 825, 830. A pathway 885 of substantiallysemi-circular cross section extends between the distal end of each nasalinsert 825, 830 to a substantially semicircular outlet 865 definedwithin the cannula's base 805. In various embodiments, when the cannula800 is in use, the user may inhale and exhale gas through this pathway885.

In certain embodiments, as discussed above, a conduit 850 is provided ineach of the nasal inserts 825, 830 (see FIG. 8C). Each of these conduits850 may be adapted to: (1) receive gas from the interior of acorresponding pathway 885 and/or from adjacent the exterior of one ofthe nasal inserts 825, 830, and (2) guide the gas out of a correspondingoutlet 835, 840 in the cannula 800. As discussed above, one or moresensors may be disposed within, or adjacent, the conduit 850 and used toassess one or more attributes of gas flowing through or adjacent theconduit 850.

It should be understood that the embodiments of the invention shown inFIGS. 4-8 and related embodiments may have utility with or without theuse of sensors or sensor conduits. It should also be understood that thevarious nasal inserts may be configured to be disposed in anyappropriate orientation within the user's nares when the cannula isoperably positioned within the user's nares. For example, in oneembodiment of the invention, the cannula may be positioned so that thecannula's nasal lumen is immediately adjacent, or so that it facesanterior-laterally away from, the user's nasal spine.

Turning to yet another embodiment of the invention, as shown in FIG. 9,the cannula 900 and corresponding sensor may be adapted so that a tubeinlet 970, 972 for at least one sensor (or the sensor itself) ismaintained adjacent, and spaced a pre-determined distance apart from,the distal end of a respective nasal insert 925, 930. In thisembodiment, the sensor (or sensor intake inlet) may be spaced apart fromthe rest of the cannula 900 adjacent one of the nasal cannula's outletopenings.

As may be understood from FIG. 10, in various embodiments, the first andsecond nozzles 1026, 1031 of the nasal cannula are configured to remainoutside of the user's nares while the cannula is in use. For example,the nozzles may be of a length such that, when the cannula is in use,the distal ends of the nozzles 1026, 1031 lie adjacent, but outside, theuser's nares. By preventing insertion of the nozzles 1026, 1031 into thenares, sealing of the nares can be avoided. As may be understood fromFIG. 13, in various embodiments, when the nasal cannula is in anoperative position adjacent the user's nares, an outlet portion (anddistal end) of each nozzle 1326, 1331 is spaced apart from, andsubstantially in-line (e.g., substantially co-axial) with, acorresponding one of the patient's nares. In various embodiments, whenthe nasal cannula is operatively in use, the outlet of each nozzle isspaced apart from the patient's nares and each nozzle is positioned todirect a focused flow of gas into a particular respective one of theuser's nares.

As may be understood from FIG. 11, in particular embodiments, a stop1190 may extend outwardly from the base portion 1105 of the cannula1100. In some embodiments, the stop 1190 lies in between the first andsecond nozzles 1126, 1131 and defines a central axis that runssubstantially parallel to the respective central axes of the nozzles1126, 1131. The stop 1190, in some embodiments, may extend outwardlyfrom the nasal cannula's base portion 1105 a length greater than that ofthe nozzles 1126, 1131. In this manner, the stop 1190 prevents thenozzles 1126, 1131 from being inserted into the user's nares when theH-aSal cannula 1100 is in use.

For example, the stop 1190 may be positioned so that when the cannula1100 is in use, the stop is designed to engage the columella of theuser's nose and thereby prevent the nozzles 1126, 1131 from beinginserted into the user's nares. In various embodiments, the first andsecond nozzles 1126, 1131 are positioned on either side of the stop 1190so that when the nasal cannula 1100 is operatively in use, the eachnozzle 1126, 1131 will be spaced apart from a respective particular oneof the patient's nares and will be positioned to direct a focused flowof gas into that particular nare by, for example, being positioned sothat the outlet (and distal end) of each nozzle (first outlet 1183 andsecond outlet 1184) is substantially in-line (e.g., substantiallyco-axial) with, a corresponding one of the patient's nares.

As may be understood from FIG. 12, in various embodiments, the cannula1200 may include only a single nozzle 1227. The nozzle 1227, in variousembodiments, has an oblong or substantially elliptical cross-section. Inthese embodiments, the major axis of the ellipse runs substantiallyparallel to the central axis of the base portion 1205 of the nasalcannula. In one embodiment, the nozzle 1227 is wide enough to allow airto flow into both of a user's nares when the nasal cannula is in use.For example, in various embodiments, the width of the nozzle 1227 (e.g.,a length defined by the major axis of the nozzle's elliptical crosssection) may be approximately equal to (or greater than) the total widthof the user's nares. In various embodiments, the cannula 1200 includes afirst tubing inlet 1217 and a second tubing inlet 1222.

As may be understood from FIG. 14, when the nasal cannula 1400 isoperatively in use, a first lateral side 1430 of the nozzle outlet 1429is spaced apart from, and adjacent, a user's first nare, and a secondlateral side 1430 of the nozzle 1429 is spaced apart from, and adjacent,the user's second nare. In this and other configurations, the nozzle1422 is configured to direct a focused flow of gas simultaneously intoeach of the user's nares. In various embodiments, when the nozzle is ofa width approximately equal to (or greater than) the total width of theuser's nares, and other widths, the nozzle 1227 is sufficiently wide toprevent the nozzle 1227 from being inserted into a user's nare, thuspreventing sealing of the nasal cannula with the nare.

In various other embodiments, the cannula's single nozzle may have adifferent cross-section that is not oblong or elliptical. For example,the nozzle may have a substantially circular cross-section, with adiameter that is wide enough to allow air to flow into both of a user'snares when the cannula is in use, while simultaneously being wide enoughto prevent insertion into a single nare. In various other embodiments,the nasal cannula may have more than one nozzle, each having asubstantially oblong cross section and a width that prevents insertioninto each of a user's nares.

In various embodiments, one or more of the cannula's elongate extensionshas a diameter that is adapted to prevent sealing with the user's nares.For example, the elongate extension(s) may have a diameter that issubstantially narrower than a user's nares, so that sealing is avoided.In other embodiments, the elongate extension(s) may include featuressuch as grooves or recesses, as described above, to prevent sealing wheninserted into a user'snare(s).

Exemplary Use of the Cannula

To use a cannula according to a particular embodiment of the invention,a physician or technician may have a patient use the cannula for a briefperiod of time, while the physician or technician monitors informationreceived from the cannula's various sensors, or the information may berecorded for later analysis. The physician or technician may then usethis information to adjust the structure or operation of the cannulauntil the cannula's sensors indicate that the patient's upper airwayenvironment satisfies certain conditions.

Similarly, in various embodiments, the cannula's sensors may be used tomonitor conditions within the patient's upper airway over time. In aparticular embodiment, the cannula's sensors may be connected to acontrol system that will automatically alter or modify the flow oftherapeutic gas into the cannula if information from the sensorindicates undesirable conditions within the patient's upper airway. Infurther embodiments of the invention, the sensor is connected to acontrol system that issues an alarm if information from the cannula'ssensors indicates undesirable conditions within the patient's airway.

FIGS. 13 and 14 depict various embodiments of nasal cannulas being usedon a patient. As may be understood from FIG. 13, for example, a nasalcannula is used on a young or small infant for high flow therapy. Forexample, a nasal cannula similar to that shown in FIG. 10 can be used.In various embodiments, first and second elongate extensions 1370, 1372are inserted into the patient's nares, while corresponding first andsecond nozzles 1326, 1331 remain adjacent and external to the patient'snares. As may be appreciated, when the nasal cannula is in use, airflows into the patient's nares via the nozzles. FIG. 14 depicts oneembodiment of a nasal cannula in use on a patient. In one embodiment, anasal cannula such as that shown in FIG. 12 can be used. As may beunderstood from FIG. 14, a nasal cannula having a single nozzle 1427 canbe used, in which the nozzle is sized and shaped (e.g., is ellipticaland/or wider than a patient's nare) to prevent insertion into thepatient's nares. In various other embodiments, nasal cannula havingnasal inserts, as described throughout, can be used. In theseembodiments, the nasal inserts are inserted into the user's nares whilethe cannula is in use. Nasal cannula according to embodiments of theinvention can be used on a variety of patients.

High Flow Therapy Device

Now referring to FIGS. 15-17, a high flow therapy device 2000 is shown.High flow therapy device 2000 is configured for use with a non-sealingrespiratory interface, such as cannula 10, for example, to deliver gasto a patient. In various embodiments, high flow therapy device 2000 isable to heat, humidify, and/or oxygenate a gas prior to delivering thegas to a patient. Additionally, embodiments of high flow therapy device2000 are able to control and/or adjust the temperature of the gas, thehumidity of the gas, the amount of oxygen in the gas, the flow rate ofthe gas and/or the volume of the gas delivered to the patient.

High flow therapy device 2000 is shown in FIG. 15 including a housing2010, a humidity chamber 2020 (e.g., vapor generator), a user interface2030, a gas inlet port 2040 and a gas outlet port 2050. A microprocessor2060, an air inlet port 2070, a blower 2080, an oxygen inlet 2090 and aproportional valve 2100 are illustrated in FIG. 16. A non-sealingrespiratory interface 100 (such as a cannula illustrated in FIGS. 1-14(e.g., 10 or 1200)), is configured to mechanically cooperate with gasoutlet port 2050 to supply a patient with gas.

A heating element 2110 is shown schematically in FIG. 17 (and is hiddenfrom view by humidity chamber 2020 in FIG. 15) is in electricalcommunication with microprocessor 2060 (which is included on printedcircuit board (“PCB”)), via wire 2112, for instance, and is capable ofheating a liquid (e.g., water) within humidity chamber 2020 to create agas. Non-sealing respiratory interface 100 is configured to deliverythis gas to a patient. Further, a sensor 2120 or transducer (shown inFIG. 20) is disposed in electrical communication with microprocessor2060 and is configured to measure pressure in the upper airway UA(including both the nasal cavity and the oral cavity) of a patient. Inan embodiment, a sensor conduit 2130 extends between the upper airway ofthe patient and sensor 2120 (FIG. 19, sensor 2120 is not explicitlyshown in FIG. 19, but may be disposed adjacent microprocessor 2060). Inanother embodiment, sensor 2120 is disposed at least partially withinthe upper airway of the patient with a wire 2122 relaying signals tomicroprocessor 2060 (FIGS. 18 and 20).

In use, a liquid (e.g., water) is inserted into humidity chamber 2020through a chamber port 2022, for instance. Heating element 2110 heatsthe liquid to create a vapor or gas. This vapor heats and humidifies thegas entering humidity chamber 2020 through gas inlet port 2040. Theheated and humidified vapor flows through gas outlet port 2050 andthrough non-sealing respiratory interface 100.

In a disclosed embodiment, sensor 2120 collects data for the measurementof the patient's respiration rate, tidal volume and minute volume.Further, based on measurements taken by sensor 2120 and relayed tomicroprocessor 2060, microprocessor 2060 is able to adjust thetemperature of the gas, the humidity of the gas, the amount of oxygen ofthe gas, flow rate of the gas and/or the volume of the gas delivered tothe patient. For example, if the pressure at the patient's upper airwayis measured and determined to be too low (e.g., by a pre-programmedalgorithm embedded on microprocessor 2060 or from a setting inputted bya operator), microprocessor 2060 may, for example, adjust the speed ofblower 2080 and/or oxygen proportional valve 2100 so that sufficientpressure levels are maintained.

Additionally, sensor 2120 may be used to monitor respiratory rates, andmicroprocessor 2060 may signal alarms if the respiratory rate exceeds orfalls below a range determined by either microprocessor 2060 or set byan operator. For example, a high respiratory rate alarm may alert theoperator and may indicate that the patient requires a higher flow rateand/or higher oxygen flow.

With reference to FIG. 17, a pair of thermocouples 2200 and 2202 isillustrated, which detect the temperature entering and leaving a circuit2210 disposed between non-sealing respiratory interface 100 and gasoutlet port 2050. Further, a second heating element 2114 (or heater)(e.g., a heated wire) may be disposed adjacent air outlet port 2050 tofurther heat the gas. It is also envisioned that second heating element2114 is disposed within circuit 2210. Thermocouples 2200 and 2202 are incommunication with microprocessor 2060 and may be used to adjust thetemperature of heating element 2110 and second heating element 2114. Afeedback loop may be used to control the temperature of the deliveredgas, as well as to control its humidity and to minimize rainout. FIG. 16illustrates an embodiment of circuit 2210 including sensor conduit 2130co-axially disposed therein, in accordance with an embodiment of thepresent disclosure.

Relating to the embodiment illustrated in FIG. 16, blower 2080 is usedto draw in ambient air from air inlet port 2070 and force it through anair flow tube 2140, through gas inlet port 2040, through humiditychamber 2020 and through gas outlet port 2050 towards non-sealingrespiratory interface 100. Blower 2080 is configured to provide apatient (e.g., an adult patient) with a gas flow rate of up to about 60liters per minute. In a particular embodiment, it is envisioned thatblower 2080 is configured to provide a patient with a gas flow rate ofup to about 40 liters per minute. Additionally, an air intake filter2072 (shown schematically in FIG. 17) may be provided adjacent air inletport 2070 to filter the ambient air being delivered to the patient. Itis envisioned that air intake filter 2072 is configured to reduce theamount of particulates (including dust, pollen, fungi (including yeast,mold, spores, etc.) bacteria, viruses, allergenic material and/orpathogens) received by blower 2080. Additionally, the use of blower 2080may obviate the need for utilization of compressed air, for instance. Itis also envisioned that a pressure sensor is disposed adjacent airintake filter 2072 (shown schematically in FIG. 17), which may becapable of determining when air intake filter 2072 should be replaced(e.g., it is dirty, it is allowing negative pressure, etc.).

With continued reference to FIG. 16, oxygen inlet 2090 and is configuredto connect to an external source of oxygen (or other gas) (notexplicitly shown) to allow oxygen to pass through high flow therapydevice 2000 and mix with ambient air, for instance. Proportional valve2100, being in electrical communication with microprocessor 2060, isdisposed adjacent oxygen inlet 2090 and is configured to adjust theamount of oxygen that flows from oxygen inlet 2090 through an oxygenflow tube 2150. As shown in FIGS. 16 and 17, oxygen flowing throughoxygen flow tube 2150 mixes with ambient air (or filtered air) flowingthrough air flow tube 2140 in a mixing area 2155 prior to enteringhumidity chamber 2020.

In a disclosed embodiment, sensor 2120 measures both inspirationpressure and expiration pressure of the patient. In the embodimentillustrated in FIGS. 18 and 19, sensor conduit 2130 delivers thepressure measurements to sensor 2120 (not explicitly shown in FIGS. 18and 19), which may be disposed adjacent microprocessor 2060. In theembodiment illustrated in FIG. 20, sensor 2120 is position adjacent thepatient's upper airway and includes wire 2122 to transmit the readingsto microprocessor 2060.

In various instances, clinicians do not desire ambient air to enter apatient's upper airway. To determine if ambient air is entering apatient's upper airway (air entrainment), the inspiration and expirationpressure readings from within (or adjacent) the upper airway may becompared ambient air pressure. That is, a patient may be inhaling gas ata faster rate than the rate of gas that high flow therapy device 2000 isdelivering to the patient. In such a circumstance (since non-sealingrespiratory interface 100 is non-sealing), in addition to breathing inthe supplied gas, the patient also inhales ambient air. Based on thisinformation, microprocessor 2060 of high flow therapy device 2000 isable to adjust various flow parameters, such as increasing the flowrate, to minimize or eliminate the entrainment of ambient air.

FIG. 21 illustrates an example of a screen shot, which may be displayedon a portion of user interface 2030. The crest of the sine-like waverepresents expiration pressure and the valley represents inspirationpressure. In this situation, ambient air entrainment into the patient'supper airway is occurring as evidenced by the valley of the sine wavedipping below the zero-pressure line. Microprocessor 2060 may beconfigured to automatically adjust an aspect (e.g., increasing the flowrate) of the gas being supplied to the patient by high flow therapydevice 2000 to overcome the entrainment of ambient air. Further,microprocessor 2060 may convey the pressure readings to the operator whomay then input settings to adjust the flow rate to minimize entrainmentof ambient air or to maintain a level of pressure above the ambient airpressure. Further, lowering the flow rates during expiration may alsominimize oxygen flow through high flow therapy device 2000. Suchlowering of a flow rate may also minimize entry of oxygen into a closedenvironment, such as the patient room or the interior of an ambulance,where high levels of oxygen might be hazardous.

In a disclosed embodiment, sensor conduit 2130 may be used as a gasanalyzer that may be configured to take various measurements (e.g.,percent of oxygen, percentage of carbon dioxide, pressure, temperature,etc.) of air in or adjacent a patient's upper airway.

In another embodiment (not explicitly illustrated), a gas port may bedisposed adjacent housing 2010 to communicate with exterior of housing2010. It is envisioned that the gas port is configured to allow the useof external devices to measure various gas properties (e.g., percentoxygen and pressure). Additionally, the gas port may be used forexternal verification of gas values. Further, a communications port2300, shown in FIG. 16, may be included to facilitate connection with anexternal device, such as a computer, for additional analysis, forinstance. Further, communications port 2300 enables connection withanother device, enabling data to be monitored distantly, recorded and/orreprogrammed, for example.

A directional valve 2160 and/or a sample pump 2170 (schematically shownin FIG. 17) may also be included to facilitate sampling the gas foranalysis. More specifically, in a particular embodiment, sample pump2170 is capable of moving a quantity of gas towards the gas analyzer. Asshown schematically in FIG. 17, the gas sample can be taken from apatient's upper airway via sensor conduit 2130 or from mixing area 2155via a sample line 2180 and a sample port 2182 (FIG. 16). Directionalvalve 2160 may be controlled by microprocessor 2060 to direct a gassample from either location (or a different location such as after thegas is heated). The gas analyzer can compare measurements of the gassample(s) with predetermined measurements to ensure high flow therapydevice 2000 is working optimally. It is further envisioned that samplepump 2170 may be configured to pump a gas or liquid towards the patientto provide the patient with an additional gas, such as an anesthetic,for instance and/or to clean or purge sensor conduit 2130.

The present disclosure also relates to methods of supplying a patientwith gas. The method includes providing high flow therapy device 2000,as described above, for example, heating the gas, and delivering the gasto the patient. In this embodiment, high flow therapy device 2000includes microprocessor 2060, heating element 2110 disposed inelectrical communication with microprocessor 2060, non-sealingrespiratory interface 100 configured to deliver gas to the patient andsensor 2120 disposed in electrical communication with microprocessor2060 and configured to measure pressure in the upper airway of thepatient. The method of this embodiment may be used, for instance, toprovide a patient with respiratory assistance. Blower 2080 may also beincluded in high flow therapy device 2000 of this method. Blower 2080enables ambient air to enter high flow therapy device 2000 (e.g.,through filter 2072) and be supplied to the patient. In such anembodiment, high flow therapy device is portable, as it does not need anexternal source of compressed air, for example.

Another method of the present disclosure relates to minimizingrespiratory infections of a patient. In an embodiment of this method,high flow therapy device 2000 includes heating element 2110 andnon-sealing respiratory interface 100. Here, a patient may be providedwith heated and/or humidified air (e.g., at varying flow rates) to helpminimize respiratory infections of the patient. Further, such a methodmay be used in connection with certain filters 2072 to help preventpatients from obtaining various conditions associated with inhalingcontaminated air, such as in a hospital. Additionally, providingappropriately warmed and humidified respiratory gases optimizes themotion of the cilia that line the respiratory passages from the anteriorthird of the nose to the beginning of the respiratory bronchioles,further minimizing risk of infection. Further, supplemental oxygen mayadd to this effect. Microprocessor 2060 in connection with sensor 2120may also be included with high flow therapy device 2000 of this methodfor measuring and controlling various aspects of the gas being deliveredto the patient, for instance, as described above.

A further method of the present disclosure relates to another way ofsupplying a patient with gas. The present method includes providing highflow therapy device 2000 including heating element 2110, non-sealingrespiratory interface 100, blower 2080, air inlet port 2070 configuredto enable ambient air to flow towards blower 2080 and filter 2070disposed in mechanical cooperation with air inlet port 2070 andconfigured to remove pathogens from the ambient air. High flow therapydevice 2000 of this method may also include microprocessor 2060 andsensor 2120.

Another method of the present disclosure includes the use of high flowtherapy device 2000 to treat headaches, upper airway resistancesyndrome, obstructive sleep apnea, hypopnea and/or snoring. High flowtherapy device 2000 may be set to provide sufficient airway pressure tominimize the collapse of the upper airway during inspiration, especiallywhile the user is asleep. High Flow Therapy (HFT) may be more acceptableto children and other who may not tolerate traditional CPAP therapy thatrequires a sealing interface. Early treatment with HFT may prevent theprogression of mild upper airway resistance syndrome to more advancedconditions such as sleep apnea and its associated morbidity.

Another method of the present disclosure is the treatment of headachesusing HFT. In an embodiment of treating/preventing headaches, gas may bedelivered to patient at a temperature of between about 32.degree. C. andabout 40.degree. C. (temperature in the higher end of this range mayprovide a more rapid response) and having at least about 27 milligramsof water vapor per liter. More specifically, it is envisioned that a gashaving a water vapor content of between about 33 mg/liter and about 44mg/liter may be used. It is envisioned that the gas being delivered tothe patient includes moisture content that is similar to that of atypical exhaled breath. In an embodiment, the flow rates of this heatedand humidified air are sufficient to prevent/minimize entrainment ofambient air into the respired gas during inspiration, as discussedabove. The inclusion of an increased percentage of oxygen may also behelpful. Further, the gas may be delivered to the patient usingnon-sealing respiratory interface 100.

High flow therapy device 2000 used in these methods includes heatingelement 2110 and non-sealing respiratory interface 100. Microprocessor2060 and sensor 2120 may also be included in high flow therapy device2000 of this method. The inclusion of blower 2080, in accordance with adisclosed embodiment, enables high flow therapy device 2000 to beportable, as it does not need to be connected to an external source ofcompressed air or oxygen. Thus, high flow therapy device 2000 of thismethod is able to be used, relatively easily, in a person's home, adoctor's office, an ambulance, etc.

The present disclosure also relates to a method of deliveringrespiratory gas to a patient and includes monitoring the respiratoryphase of the patient. Monitoring of a patient's respiratory phase isenabled by taking measurements of pressure in a patient's upper airway.Additionally, respiratory phase may be determined by pressure withcircuit 2210 or by monitoring activity of the phrenic nerve. Real-timepressure measurements (see sine-like wave in FIG. 21, for example)enable real-time supplying of gas at different pressures to be deliveredto the patient, or variable pressure delivery. For example, gas at ahigher pressure may be delivered to the patient during inspiration andgas at a lower pressure may be delivered to the patient duringexpiration. This example may be useful when a patient is weak and hasdifficultly exhaling against an incoming gas at a high pressure. It isfurther envisioned that the pressure level of the gas being delivered toa patient is gradually increased (e.g., over several minutes) to improvepatient comfort, for instance.

With reference to FIGS. 22-24, mouthpiece 3000 is illustrated inaccordance with an embodiment of the present disclosure. As brieflydescribed above, mouthpiece 3000 is an example of a respiratoryinterface of the present disclosure. Mouthpiece 3000 (illustratedresembling a pacifier) may be used to detect upper airway pressure of apatient.

A first mouthpiece port 3010 may be used to measure pressure insidemouthpiece 3000 through open end 3012 of first port. First mouthpieceport 3010 may include an open-ended tube that communicates the pressurewith mouthpiece 3000 to sensor 2120 (not explicitly shown in FIGS.22-24) via first port conduit 2130 a. Sensor 2120 may also be positionedwithin mouthpiece 3000. It is envisioned that mouthpiece 3000 is atleast partially filled with a gas or liquid, e.g., water.

The pressure within mouthpiece 3000 may help evaluate, record orotherwise use the pressure data for determining the strength of suckingor feeding, for instance. The timing of the sucking motion and thedifferential pressures in the mouth may also be measured. The suckingpressure may be used to help determine the strength of the sucking andmay be used to evaluate the health of an infant, for instance. Themeasurement of oral-pharyngeal pressure may also give data for settingor adjusting respiratory support therapy for the patient. It isenvisioned that a relatively short first mouthpiece port 3010 may beused so that a bulb 3030 of mouthpiece 3000 acts as a pressure balloon.It is also envisioned that a relatively long first mouthpiece port 3010having rigidity may be used to help prevent closure of the tube frompressure from alveolar ridges or from teeth, for example.

A second mouthpiece port 3020 is configured to enter a patient's mouthor oral cavity when mouthpiece 3000 is in use and is configured tomeasure pressure within the oral cavity (upper airway pressure) throughan open end 3022 of second mouthpiece port 3020. Pressure from withinthe upper airway (e.g., measured adjacent the pharynx) may betransmitted to sensor 2120 via second port conduit 2130 b or sensor 2120may be positioned adjacent mouthpiece 3000. That is, the pressurecommunicated from with the upper airway to the patient's mouth is thepressure being measured. It is envisioned that second mouthpiece port3020 extends beyond a tip of bulb 3030 to facilitate the acquisition ofan accurate upper airway pressure measurement.

Referring to FIG. 23, a balloon 3040 is shown adjacent a distal end 3024of second port 3020. Here, it is envisioned that a lumen of conduit 2130b is in fluid communication with the internal area of balloon 3040.Further, any forces against a wall of balloon 3040 are transmittedthrough the lumen towards sensor 2120 or transducer for control,observation or analysis.

The pressure within the oral cavity may vary during the phases ofsucking and swallowing. High flow therapy device 2000 using mouthpiece3000 enables concurrent measurement of sucking pressure withinmouthpiece 3000 and the pressure outside mouthpiece 3000. This data mayhelp determine treatment characteristics for respiratory support forinfants, children or adults, e.g., unconscious adults.

In an embodiment of the present disclosure, high flow therapy device orsystem 2000 includes microprocessor 2060, heating element 2110, humiditychamber 2020, circuit 2210, blower 2080 and a feedback system. Theheating element 2110 is disposed in electrical communication with themicroprocessor 2060 and is capable of heating a liquid to create a gas.The humidity chamber 2020 is disposed in mechanical cooperation with theheating element 2110. The circuit 2210 is adapted to direct the gastowards a patient. The blower 2080 is disposed in electricalcommunication with the microprocessor 2060 and is capable of advancingthe gas at least partially through the circuit 2210. The feedback systemis configured to control a volume of gas being directed towards thepatient.

In an embodiment, it is envisioned that at least one gas flow sensor2120 is disposed in electrical communication with the microprocessor2060 and is configured to detect at least one flow characteristic of thegas. It is envisioned that high flow therapy system 2000 includes atleast one compressed gas entry port 2090. Further, a pulse oximeter (seeFIG. 17A), as discussed below, may be incorporated into high flowtherapy system of the present disclosure.

The present disclosure also relates to a high flow therapy system 2000including a microprocessor 2060, a heating element 2110, a humiditychamber 2020, a circuit 2210, at least one proportional valve 2132 (seeFIGS. 32A and 32B) and a feedback system. The heating element 2110 isdisposed in electrical communication with the microprocessor 2060 and iscapable of heating a liquid to create a gas. The humidity chamber 2020is disposed in mechanical cooperation with the heating element 2110. Thecircuit 2210 is configured to direct the gas towards a patient. The atleast one proportional valve 2132 is disposed in electricalcommunication with the microprocessor 2060 and is configured to helpcontrol the entry and passage of gas. The feedback system is configuredfor controlling a volume of gas directed towards the patient. It isnoted that, while the blower 2080 is not necessarily part of the otherembodiments of the present disclosure, this embodiment specifically doesnot include a blower 2080.

It is envisioned that the high flow therapy system 2000 of thisembodiment includes at least one gas flow sensor 2120 disposed inelectrical communication with the microprocessor 2060 and is configuredto detect at least one flow characteristic of the gas.

The present disclosure also relates to a method for delivering heatedand humidified gas to a patient. The method includes the steps ofproviding a high flow therapy device, providing a non-sealingrespiratory interface (e.g., 100), providing a sensor 2120, deliveringgas from the high flow therapy device to a patient, and measuring theflow rate of the gas delivery to the patient. The high flow therapydevice includes a heating element 2110 capable of heating a liquid tocreate a gas. The non-sealing respiratory interface is disposed inmechanical cooperation with the high flow therapy device and isconfigured to direct the gas towards a patient. The sensor is disposedin electrical communication with a microprocessor 2060 of the high flowtherapy device and is configured to measure a flow rate of the gasdelivered to the patient. An optional step of the method includesincreasing (e.g., gradually increasing) the flow rate of the gasdelivered to the patient.

The present disclosure relates to a gas delivery conduit adapted forfluidly connecting to a respiratory gases delivery system in a high flowtherapy system. In one embodiment, the gas delivery conduit includes afirst connector adapted for connecting to the respiratory gases deliverysystem, a second connector adapted for connecting to a fitting of apatient interface and tubing fluidly connecting the first connector tothe second connector where the first connector has a gas inlet adaptedto receive the supplied respiratory gas. In one aspect of thisembodiment, the gas delivery conduit includes one of electrical contactsand temperature contacts integrated into the first connector. In anotheraspect of this embodiment, the gas delivery conduit includes a sensingconduit integrated into the gas delivery conduit. In yet another aspectof this embodiment, the first connector of the gas delivery conduit isadapted to allow the user to couple the first connector with therespiratory gases delivery system in a single motion. In yet anotheraspect of this embodiment, the first connector of the gas deliveryconduit is adapted to allow the user to couple the first connector withthe respiratory gases delivery system by moving the connector in adirection along an axis of the gas inlet.

With reference to FIGS. 25-28, a connector 4000 for use a system fordelivery of respiratory gases (e.g., high flow therapy device 2000) isshown. Connector 4000 includes a gas lumen 4010 and a pressure conduit4020. Gas lumen 4010 is configured to link a gas outlet 4110 of atherapy device 4100 (e.g., high flow therapy device 2000) with a gasinlet 4210 of a delivery conduit 4200. Pressure conduit 4020 of deliveryconduit 4200 is configured for engagement with at least one of apressure port and a pressure sensor (collectively referred to aspressure port 4120 herein) of therapy device 4100. It is envisioned thata seal 4122 (e.g., an O-ring seal) is disposed adjacent pressure port4120 (see FIGS. 25 and 27). FIG. 25 also illustrates a tubing 4300 thatallows passage of the respiratory gases from connector 4000 to thesecond connector 5000 (which is described in further detail below). Inembodiments, tubing 4300 may be corrugated as shown.

In the embodiment illustrated in FIG. 26, connector 4000 also includestwo temperature sensor contacts 4030 a, 4030 b for two temperaturesensors (e.g., thermistor or thermocouple) 4230 a, 4230 b of deliveryconduit 4200 (shown in FIG. 28 on a lead wire) configured for engagementwith temperature sensor contacts 4130 a, 4130 b of therapy device 4100.FIG. 26 also illustrates an electrical contact 4040 disposed onconnector 4000. Electrical contact 4040 is configured for engagementwith an electrical contact 4140 of therapy device 4100 and electricalengagement with a heating element 4240 of delivery conduit 4200. It isenvisioned that electrical contact 4040 is configured to signalmicroprocessor 2060 to provide power to a heat transfer plate 4610(discussed below) and/or heating element 4240.

With specific reference to FIG. 27, an inlet portion 4220 of pressureconduit 4020 of connector 4000 is coaxially disposed with gas lumen 4010of connector 4000, and an outlet portion 4222 of pressure conduit 4020is coaxially disposed with pressure port 4120 of therapy device 4100. Itis envisioned that connector 4000 is also configured to convey gas,electricity and/or light between a patient delivery conduit 4200 andtherapy device 4100.

It is therefore envisioned that various connections may be made with asingle motion. That is, a gas connection, a pressure connection, atleast one temperature sensor contact connection and an electricalconnection may be made by approaching connector 4000 (coupled todelivery conduit 4200) with therapy device 4100.

It is further envisioned that connector 4000 is configured to connect atleast one optical fiber, electrical wire and/or pressure conduit from adelivery conduit 4200 with therapy device 4100 in a single motion. Thismay be helpful when sensing temperature, pressure, flow, CO₂, O₂,Oxyhemoglobin saturation and other clinical measures from sensorsoperatively coupled to an airway interface or therapy device 4100.

Pulse oximetry, carbon dioxide and O₂ detection may thus be integratedinto the HFT device (e.g., 4100) helping allow alarms to be incorporatedbased on data from at least one of a gas sensor, pulse oximetry,respiratory rate, tidal volume, pressure and from synthesis of clinicaldata. For instance, HFT device 4100 may include a pulse oximeter(schematically illustrated in FIG. 17A as part of printed circuit boardbox 2060). Pulse oximeter 2060 may be in the form of a microchip coupledwith the printed circuit board and may include a probe 2062 and a wire2064. In a disclosed embodiment (see FIG. 35), probe 2062 is connectableto a patient's ear lobe and wire 2064 connects probe 2062 with printedcircuit board 2060 of HFT device 4100.

The HFT system may calculate cardiac output from data gathered fromsensors. Data from sensors may be used in a feedback system to controlat least one of FiO₂ and flow rate. The system may limit control towithin pre-selected ranges. For example, FiO₂ could be set to bedelivered in a range from about 21 percent to about 30 percent dependingon pulse oximetry results, and an alarm could notify if the O₂saturation from pulse oximetry fell below a set value for example, below90 percent.

FIGS. 32A and 32B illustrate a schematic diagram of a further embodimentof an HFT device that allows for relatively low percentage gas mixtures,for example low FiO₂ when O₂ is mixed with air. In weaning a patientfrom O₂ therapy, it may be desirable to decrease a patient from a highpercentage of FiO₂ to a low percentage of FiO₂, and in this case verysmall flows of O₂ may be needed in a mixture with air. For example, todeliver an FiO₂ of 25 percent at 5 liters per minute, as may be used inHFT in neonates; about 4.75 liters of air would be mixed with 0.025liters of O₂. Conversely, to get a mixture of gases at higher ranges ofO₂, low amounts of air would be mixed with O₂. The schematic illustrateshow two proportional valves 2132 may be used to control flow over awider range than would be effective with a single proportional valve.Also shown is how a single sensor may be configured to sense flow fromtwo flow tubes (e.g., pneumotachs), in this instance, one for high andone for low volume flows.

HFT may be desirable for use in patients in locations where compressedor liquid O₂ is not readily or economically feasible. For patients whomay benefit from oxygen therapy, an HFT device (e.g., 4100) may delivergas from an oxygen concentrator. This gas may be mixed with room air. If20 liters per minute room air is mixed with 6 liters per minute of O₂from an oxygen concentrator delivering O₂ at 85% purity, the deliveredgas mixture will have an O₂ concentration of about 36%. A higherconcentration may be reached with the use of more than one oxygenconcentrator.

The present disclosure also relates to a high flow therapy system 4500including delivery conduit (such as delivery conduit 4200 describedherein), therapy device (such as therapy device 4100 described herein),and connector (such as connector 4000 described herein). Deliveryconduit 4200 is configured to direct gas towards a patient interface.Therapy device 4100 is configured to supply gas through a humiditychamber 4600 to delivery conduit 4200. Connector 4000 is configured tooperatively connect delivery conduit 4200 with therapy device 4100,e.g., in a single motion. As shown in FIG. 25, in embodiments connector4000 is configured to operatively connect delivery conduit 4200 withtherapy device 4100 and humidity chamber 4600, e.g., in a single motion.Specifically, gas outlet 4110 of humidity chamber 4600 receives gaslumen 4010 of connector 4000, and receptacle 4150 of therapy device 4100receives a flange 4250 of connector 4000. As is understood by oneskilled in the art, flange 4250 would serve to orient connector 4000relative to therapy device 4100 in order to facilitate alignment ofpreviously mentioned temperature contacts, electrical contacts, pressureports, etc. that may exist on both delivery conduit 4200 and therapydevice 4100. In embodiments and as shown in FIGS. 25-26 gas outlet 4110may have a first cylindrical portion and gas lumen 4010 may have asecond cylindrical portion. It is understood that each cylindricalportion would have an axis. FIG. 27 shows a gas lumen axis 4011 and agas inlet axis 4211. FIG. 27 also shows that outlet portion 4222 canhave a cylindrical portion having an outlet port axis 4221. As shown inFIG. 27, in embodiments gas inlet axis 4211 may not be parallel tooutlet port axis 4221.

With reference to FIGS. 29-29C, various embodiments of a humiditychamber 4600 use with a therapy device (e.g., therapy device 4100) areshown. With particular reference to FIGS. 29 and 29A, humidity chamber4600 includes heat transfer plate 4610 (e.g., made of aluminum) and ahousing 4620 (e.g., made of thermoplastic). Housing 4620 includes aflange 4622 and a fixed barrier 4624. Flange 4622 is configured forengagement with a lip 4612 of heat transfer plate 4610. Fixed barrier4624 extends along at least a portion of flange 4622 and is configuredto shield an edge 4614 of heat transfer plate 4610.

As shown in FIG. 29B, an embodiment of humidity chamber 4600 includes anoverhang 4626 extending from flange 4622/barrier 4624 and also includesa protrusion 4628 shown extending substantially vertically from flange4622.

In the embodiment shown in FIG. 29C, humidity chamber 4600 also includesa plurality of ribs 4630 extending from a portion of housing 4620 andflange 4622. It is envisioned that a distance “d” between adjacent ribs4630 is sufficiently small enough to prevent a user's finger fromcontacting flange 4622. For example, distance “d” may be between about0.5 cm and about 1.0 cm.

As can be appreciated, various features of FIGS. 29-29C are helpful inprotecting users from contacting a heated surface. Heat transfer plate4610 is disposed in thermal communication with a heater plate (notexplicitly shown in FIGS. 29-29C) of therapy device 4100. Thus, heattransfer plate 4610 (e.g., edge 4614 of heat transfer plate 4610) mayreach a temperature that exceeds safety standards for an exposedsurface. In the present disclosure, flange 4622 is positionable adjacentlip 4612 of heat transfer plate 4610 to help prevent an exposed surfacefrom exceeding an allowable amount. The inclusion of other features(e.g., fixed barrier 4624, overhang 4626, protrusion 4628, and pluralityof ribs 4630) of the present disclosure may further help prevent a userfrom being able to contact a surface having a temperature that exceedssafety standards.

Additionally, humidity chamber 4600 may also include a bonding agent4640 disposed between lip 4612 of heat transfer plate 4610 and flange4622 of housing 4620. Bonding agent 4640 (e.g., made from Dymax MedicalClass VI Approved UV Cure Acrylic adhesive, or Star*Tech Medical ClassVI Approved UV Cure Acrylic Adhesive) may be configured and positionedto provide a substantially watertight seal between heat transfer plate4610 and housing 4620.

An embodiment of the present disclosure includes a humidity chamber 6000that may be opened and washed (e.g., in a dishwasher), as shown in FIGS.33A-33C. This allows for more economic use of an HFT device in the home.The upper housing 6010 is open and configured to mate with a seal 6020(e.g., rubber or silicone) and a lid 6030. While various structures maybe used to allow for a removable portion (e.g., a removable lid), thefigures show the lid 6030 having one or more detachable hinges 6040 a,6040 b on one surface that allow the lid 6030 to swing open to fill orrefill the chamber. On the opposite surface a latch 6050 is included tohelp seal the lid 6030 closed. It is envisioned that the lid 6030 can bedetached for washing.

With continued reference to FIGS. 33A-33C, humidity chamber 6000illustrated in this embodiment also includes a gas inlet 6060, a gasoutlet (not explicitly shown in the illustrated embodiments), acondensation bar 6070, finger protection flanges 6080, an overhang 6090and a depression 6100 in lid 6030. Condensation bar 6070 is configuredto help keep condensation from running out in rear of chamber when lid6030 is open for refilling. It is envisioned that the chamber isconfigured to allow refilling without removing the chamber from the HFTdevice and thus allows fluid to be poured therein rather than solelyrelying on refilling via an IV bag. As shown, front latch 6040 b helpsenable lid 6030 to open. Overhang 6090 is configured to help seat lid6030 correctly and to hold seal 6020 in place. Depression 6100 in lid6030 is configured to act as a low point for the drippage ofcondensation.

Referring now to FIGS. 30 and 31, a second connector 5000 for use with atherapy device (e.g., therapy device 4100) is shown. Second connector5000 includes a conduit fitting 5100 for connecting to a cannula fitting5200 of a patient interface. Conduit fitting 5100 includes a gas lumen5110 and a pressure lumen 5120. Gas lumen 5110 is configured to directgas from therapy device 4100 towards a patient interface (e.g.,nonsealing respiratory interface 100). Pressure lumen 5120 is configuredto convey pressure from a patient interface 100 towards pressure port4120 of therapy device 4100. Cannula fitting 5200 is configured forreleasable engagement (e.g., coaxial engagement) with conduit fitting5100 and includes at least one gas lumen 5210 and at least one pressurelumen 5220. The at least one gas lumen 5210 of cannula fitting 5200 isconfigured to direct gas from therapy device 4100 towards patientinterface 100. The at least one pressure lumen 5220 is operativelyengageable with pressure lumen 5120 and is configured to convey pressurefrom patient interface 100 towards pressure port 4120 of therapy device4100.

In the illustrated embodiments, a distal portion 5202 of cannula fitting5200 includes two gas lumens 5210 a and 5210 b, which are in gaseouscommunication with gas lumen 5210 c of a proximal portion 5204 ofcannula fitting 5200. The illustrated embodiments also illustrate distalportion 5202 of cannula fitting 5200 includes two pressure lumens 5220a, 5220 b in gaseous communication with pressure lumen 5220 c ofproximal portion 5204 of cannula fitting 5200. In these embodiments, gasmay be supplied to and/or pressure may be taken from each of a patient'snostrils.

With continued reference to FIGS. 30 and 31, second connector 5000further includes at least one spoke 5300 (three spokes 5300 a, 5300 band 5300 c are shown) connecting a wall 5106 of conduit fitting 5100 anda wall 5122 of pressure lumen 5120 of conduit fitting 5100. Spoke 5300is configured to allow axial movement (e.g., in the substantialdirections of arrow “A” in FIG. 30) of pressure lumen 5120 of conduitfitting 5100 relative to wall 5106 of conduit fitting. Thus, a pressureseal may be created between pressure lumen 5120 of conduit fitting 5100and at least one pressure lumen 5220 of cannula fitting 5200 prior to agas seal being created between gas lumen 5110 of conduit fitting 5100and at least one gas lumen 5210 of cannula fitting 5200. That is, atleast one spoke 5300 facilitates a single-motion connection betweenconduit fitting 5100 and cannula fitting 5200, e.g., by allowingpressure lumens 5120, 5220 to axially move together, while attempting tooperatively couple (e.g., create a gas seal) gas lumens 5110, 5210.

It should also be noted that while spokes 5300 are illustrated anddescribed as being part of conduit fitting 5100, it is envisioned andwithin the scope of the present disclosure to include at least one spoke5300 on cannula fitting 5200 in addition to or alternatively fromproviding at least one spoke 5300 on conduit fitting 5100.

An embodiment of the present disclosure also relates to a therapy deviceincluding a gas delivery conduit that allows for delivery of therapeuticgases that may be warmed and humidified and delivered to a subject. Asecond conduit allows pressure from the subject's airway to becommunicated to a sensor within the therapy device. This second conduitmay be a gas conduit and may also allow for sampling of gas from thesubject's airway. Such an embodiment may be useful, for example, indetermining the expiratory CO₂ of the subject using the device.

In another embodiment, one or more pressure, temperature or othersensors may be placed in the subject's airway and may be used to providedata about the status of the subject receiving therapy and the subject'sinteraction with the therapy. Such sensors may be in electricalcommunication with a microprocessor 2060, and electric wires may beconfigured to follow or be within the delivery conduit. Data fromsensors may also be transmitted optically. Optical fibers may transmitlight that may be used to determine data about the subject's status andabout the subject's interaction with the therapy. Optical fibers may beused in conjunction with certain sensors or in collaboration withelectrical sensors. Further, optical fibers may be configured to followor be disposed within the delivery conduit. The connector used in thisembodiment may include contacts for a gas port for sensors, electricalcontacts for sensors and/or optical connectors.

Running the HFT unit without water could deliver dry warm air to theuser. One aspect of the present disclosure is the ability of the unit togive a signal, which notifies the user that the unit has run low onwater or is out of water to supply the needs to humidify the gasdelivered. At least one of temperature data and power data of theheaters can be used to determine status of the water level in thehumidity chamber 2020. Additional aspects of the present disclosureinclude the ability of the unit to signal a low water status, and toshut itself off or re-adjust flow and heater settings in response to lowwater. Another aspect of the present disclosure is the ability totrigger automatic refilling of the humidity chamber with water, byopening a valve controlling the inlet of an appropriate amount of waterupon a signal from the microprocessor 2060.

After use, water or moisture may remain in the humidity chamber 2020 orconduit. This is a potential area for growth of microbes. Another aspectof the present disclosure is a drying cycle, where the heater and blowerare active, and run until the humidity chamber 2020 and the conduit aresubstantially dry. This helps prevent the growth of common microbes inthe humidity chamber 2020 and the conduit. It is envisioned thatmonitoring at least one of temperature and current use by the unit helpscontrol the drying cycle. That is, it is envisioned that microprocessor2060 is able to detect changes in electrical current use and/ortemperature data and can use this information to determine that theamount of water in the humidity chamber is inadequate for continued use.In response to an inadequate amount of water, microprocessor 2060 maytrigger an auditory and/or visual signal, may trigger a mechanism (e.g.,water supply) to add water to the chamber, and/or may adjust thedelivered gas flow temperature and/or flow rate.

FIGS. 34A-34D illustrate a saddle 7000 where a portion of the conduitmay be seated. In one configuration, the user places a portion of theconduit in a saddle 7000, or other connector. It is envisioned that whenthe conduit in positioned in the saddle 7000, a signal is sent to theunit to run the drying cycle until the humidity chamber 2020 and theconduit are dry and then to turn the unit off. It is also envisionedthat the saddle 7000 is configured to help prevent the unit from beingused by a patient during the drying cycle, which may operate at highertemperatures. In such an embodiment, it is envisioned that there aresensors 7100 a, 7100 b (e.g., electrical sensors, magnetic sensors,mechanical sensors, etc.) disposed on the saddle 7000 and the conduitthat must be engaged with one another to enable the drying cycle to run.

The present invention is a respiratory gas delivery system that delivershigh flows (i.e. high flow therapy) through a non-sealing patientinterface. This High Flow Therapy (HFT) system is comprised of a HFTdevice (i.e. the main device) and its accessories, which are describedin further detail throughout. The HFT device can provide respiratorysupport for patients ranging from neonates to adults. The HFT device canlower respiratory rates, improve secretion clearance, and reduce thework of breathing. The HFT device can relieve respiratory disorders thatrespond to certain levels of positive airway pressures, such as asthma,bronchitis, sleep apnea, snoring, COPD, and other conditions of therespiratory tract. For example, the HFT system could deliver up to 35 cmH₂O of airway pressure. The HFT device can treat hypothermia and aid inwashout of anesthetics after surgery. It is envisioned that the HFTdevice may have applications similar to those prescribed hypobaricchambers, such as brain or head injury (e.g. concussions). The presentdisclosure relates to a high flow therapy system for delivering heatedand humidified respiratory gas to an airway of a patient. The HFT devicecan generate flows that are continuous. The HFT system delivers thegases to the patient via a non-sealing patient interface (e.g. nasalcannula) utilizing an “open flow” method of delivery. “Open Flow”specifies that the cannula in the patient's nose does not create a sealor near seal.

The HFT device is an all-in-one device that allows for control of gasflow, gas oxygen concentration, gas temperature, and gas humidity in asingle device or system. This includes delivering gases at flow rates upto 60 L/min, oxygen concentrations up to 100%, gases heated from 30 to40 degrees Celsius, and humidified gases up to 100% relative humidity.The is vastly superior to basic oxygen delivery systems that are limitedto gas flows of up to 8 L/min, have no gas temperature control, and haveno gas humidity control. Because basic oxygen delivery systems have nogas temperature or gas humidity control, gas flows higher than 8 L/minare not well tolerated by the patient. In contrast, the HFT device candeliver higher flow rates that are easily tolerated in the nasalpassages when the gas is warm and humid. The high flow also assures thatthe patient's inspired volume may be almost entirely derived from thegas delivered (i.e. minimized or no mixture of delivered gas withambient air). The HFT system may generate a positive pressure in theairways during inhalation and/or exhalation, even though the system isan open system (i.e. does not use a sealing patient interface).

An all-in-one HFT device allows for more control and more accuracy ofthe gas conditions being delivered. It also provides the opportunity toprovide feedback to the operator and to provide feedback loop control ofthe HFT device through for example gas sensing. Finally, an all-in-oneHFT device allows for improved communications and alarms to theoperator. For example, the HFT device may gather airway pressureinformation through its pressure sensing technology described throughoutand use that information to adjust flow rates (either manually by theoperator or automatically by the HFT device) in order to control airwaypressures (e.g. prevent unintended high pressures).

The HFT system is a microprocessor-controlled respiratory gas deliverysystem that provides continuous flows of heated and/or humidified airand/or oxygen mixtures to patients. FIG. 36 illustrates of an embodimentof a HFT device 8000 of a HFT system that is positioned on a platform2900 of a cart 8900 and coupled with a water bag 8920. FIG. 37illustrates an exploded view of some of the main components of an HFTsystem, including the HFT device 8000, the water chamber 8600, thedelivery circuit 8700, and the patient interface 8800. FIG. 38illustrates an assembled view of some of the main components of an HFTsystem. FIG. 39 illustrates a schematic view of some of the maincomponents of an HFT system. The HFT device 8000 can be controlled by amicroprocessor on a main PCB (printed circuit board) 8060. The operatorof the HFT device inputs settings, such as gas flow rate, gastemperature, gas oxygen concentration, gas humidity levels, etc. via theHFT device's user interface for the microprocessor to control. The userinterface may be a graphical user interface (GUI). The user interfacemay contain information such as graphs (e.g. pressure waveform),numbers, alpha characters, help menus, etc. The user interface may beshown on a display 8030. The display 8030 can have a touch screen thatallows the operator make inputs to the HFT device. The display 8030 canbe rotated, for example up to 360 degrees, to facilitate viewing orentry. The display 8030 can be pivoted or tilted, for example from 0 to180 degrees, to facilitate viewing, entry, or shipping. The display 8030can be removable to facilitate shipping, servicing, or to be used as aportable user interface. The HFT device can also include push buttons orknobs as part of the user interface system. In alternative embodiments,the information on the display 8030 may be projected by the HFT device(e.g. on a wall or on a table) or the information may be transmittedonto another device, such as a hand held device or computer. In anotheralternative embodiment a separate device, such as phone, tablet, orcomputer may couple with the HFT device in lieu of the display 8030 ormay transmit information to the HFT device in order to serve as the userinterface.

The HFT device 8000 may have an enclosure with an upper enclosureportion 8010 and a lower enclosure portion 8020 as shown in FIG. 37.FIG. 40 illustrates a top perspective view of the HFT device 8000 withthe upper enclosure portion 8010 removed to show some of the internalcomponents. FIG. 41 illustrates a rear perspective view of the HFTdevice 8000 with the upper enclosure portion 8010 removed to show someof the internal components. FIG. 42 illustrates a top view of the HFTdevice 8000 with the upper enclosure portion 8010 removed, the heaterplate 8050 shown transparent, and the outlet adapter 8040 showntransparent to show some of the internal components. The HFT device 8000may have a battery 8070 so that it may work, at least partially, as aportable device, without being plugged in, or without wall power (e.g.as a backup battery in a power outage). The HFT device may be mounted ona pole 8930, on a cart 8900, or may be configured to be placed on atable, desk, or nightstand.

Medical grade air and/or medical grade oxygen, for example from hospitalgas supply systems or compressed gas tanks, may be used with the HFTsystem. Other gases, such as helium, may be substituted for the air oroxygen. An inlet filter 8080 (e.g. a water trap) can be connectedbetween a gas source and the HFT device 8000 via a fitting 8082 (e.g.DISS fitting). The inlet filter 8080 could be internal or converselyexternal to the HFT device so it is visible and accessible for service.The pressurized gas (e.g. air or oxygen from the facility at 50 psi)then enters the HFT device 8000 and its flow system. There may be twoinlet filters as shown in FIG. 41. There may be two different fittings(e.g. fitting 8082 and second fitting 8084) for connecting the HFTdevice 8000 with different gas sources.

The HFT device can have an integrated flow adjustment system to deliverthe set flow rate and/or oxygen concentrations to the patient. Flowcontrol can be achieved automatically through the interaction betweenthe system electronics (e.g. the microprocessor) and the flow system.The flow system can consist of valve systems. Valve systems can be usedfor air and/or oxygen gas flow regulating and metering. The valvesystems can be partially or completely enclosed in the RFT device.

A valve system 8100 can be a manifold 8110 (e.g. a molded housing ormachined block of plastic or aluminum). A manifold 8110 can have onemanifold inlet 8112, one manifold outlet 8114, and one manifold flowpath there between. In an alternate embodiment, a single manifold canhave a first manifold inlet, a first manifold outlet, and a firstmanifold flow path there between, as well as a second manifold inlet, asecond manifold outlet, and a second manifold flow path there between.In a preferred embodiment, there are two valve systems inside theunit—one for air and one for oxygen. A regulator 8120 can be mounted onthe manifold 8110. The regulator 8120 can reduce the gas pressure fromits initial pressure (e.g. 50 psi) to a lower or constant pressure thatis optimal for subsequent flow rate control inside the device. Thepressurized gas flows from the manifold inlet 8112 to the regulator 8120that is mounted on the manifold 8110. After leaving the regulator 8120,the gas flows through a proportional valve 8130 that can also be mountedon the manifold 8110. The proportional valve 8130 can be apiezo-actuated proportional valve. The proportional valve 8130 canoutput a gas flow rate proportional to a signal voltage. Theproportional valve 8130 is normally closed when no gas flow is requiredthrough the valve. In a preferred embodiment, each valve system can havetwo proportional valves, where a first proportional valve accommodateshigher flow rates (e.g. 50 L/min) and a second proportional valveaccommodates lower flow rates (e.g. 1 L/min). In this embodiment, thetwo proportional valves may work independently or may work incooperation.

The valve system 8100 can have a mass flow sensor 8140 coupled with themanifold 8110 to measure the flow rate of the gas. The mass flow sensor8140 is coupled to a manifold PCB (printed circuit board), which can bemounted to the manifold 8110. The manifold PCB is electrically connectedto the main PCB 8060 to communicate input/output signals and power. Thissystem can be referred to as a 2-position (i.e. on and off), 2-way (i.e.gas in and gas out) piezo-based valve system with integral mass flowmetering system. This system can be described as a low-power,highly-sensitive piezo valve working in conjunction with a mass flowsensor and with control loop electronics to achieve accurate flow rateswith little power consumption. The results are that the valve systemscan be very quiet and cool, eliminating the needs for fans or secondarycooling devices (e.g. heat sinks) inside the HFT device. This integratedflow adjustment system described in the sections above forms a controlloop by which the gas flow may be adjusted by the software of the HFTdevice.

Gas exists the manifold 8110 through the manifold outlet 8114. In anembodiment with two manifolds (i.e. one for each gas), the gases exittheir respective manifolds and stream together to mix. This mixing canoccur in a tube, a mixing chamber, a blender, etc. In an embodiment withone manifold for two different gases, the gases may stream togetherwithin the manifold to mix prior to exiting the manifold (i.e. twomanifold inlets and one manifold outlet).

In another embodiments, the HFT device can entrain air from ambientinstead of receiving it from a compressed gas source. In yet anotherembodiment, the HFT device can have an integral blower for air toadvance the gas. Both of these embodiments could replace the air valvesystem and integrate with the flow adjustment system. Gas from theseembodiments could still mix with the oxygen downstream as previouslydescribed.

Mixed gases can then proceed towards and through an outlet adapter 8040.Pressure inside the outlet adapter 8040 can be measured by a drivepressure sensor 8062. The drive pressure sensor 8062 can be located onthe main PCB 8060 and can be pneumatically connected to the bore of theoutlet adapter 8040 by a length of flexible tubing. If the pressureinside the outlet adapter 8040 exceeds a certain pressure (e.g. 1 psi),the gas may be vented out of the outlet adapter 8040 through a reliefvalve 8046.

The end of the outlet adapter 8040 may protrude outside the HFT device8000 enclosure. The outlet adapter 8040 can feature an oxygen analyzerport 8042 into which an oxygen analyzer may be connected to for oxygenconcentration (e.g. FiO₂) verification purposes. The oxygen analyzerport 8042 may be closed by a valve, plug, or cap when an analyzer is notin use. Such a feature may be coupled or integral with the outletadapter 8040 to close off the oxygen analyzer port 8042. An analyzeradapter may be inserted into the oxygen analyzer port 8042 to allow thefit of different sizes of oxygen analyzers. In one embodiment, ananalyzer adapter 8044 may be integrated into the outlet adapter.

An outlet filter 8090 may be connected to the outlet adapter 8040 (e.g.via press fit). This outlet filter may have viral and/or anti-bacterialproperties. The outlet filter 8090 serves to keep bacteria, viruses,volatile organic compounds, etc. from entering the water chamber andeventually reaching the patient. The outlet filter 8090 also serves tokeep water, humidity, bacteria, viruses, etc. from entering the HFTdevice itself. This keeps undesirable matter from collecting inside theHFT device and potentially being transmitted to the next patient thatuses the HFT device. The outlet filter 8090 therefore is a safetycomponent to reduce risks to the HFT device and the patient from use ofthe HFT device. The outlet filter 8090 may have a outlet filter gassampling port 8092. The outlet filter 8090 may have a straight, angled,or staggered filter body portion, filter inlet gas port, and/or filteroutlet gas port. The end of the outlet adapter 8040 may be closed by avalve, plug, or cap when the outlet filter 8090 is not engaged, forexample between use of the HFT device on different patients. Such afeature may be coupled or integral with the outlet adapter 8040 andwould serve to protect the inside of the HFT device when an outletadapter 8040 is not present.

The outlet filter and the other components downstream may be consideredsingle use, single patient use, or disposable components. Thesecomponents may include a water chamber, a delivery circuit, a patientinterface (e.g. cannula; mask; or artificial airways such asendotracheal tubes, nasotracheal tubes, and tracheotomy tubes), a tee,and/or other fittings. It is preferred that the patient interface be anon-sealing interface (i.e. not intended to form a substantial seal withthe patient), such as a non-sealing nasal cannula.

The water chamber 8600 slides into the HFT device 8000 and subsequentlyengages with outlet filter 8090 (via a friction fit). The HFT device hasreceiving flanges that couple with the water chamber 8600. The receivingflanges can be spring loaded to facilitate securing the water chamber8600 and/or to facilitate keeping contact between the heat transferplate of the water chamber 8600 and the heater plate 8050. The waterchamber 8600 can maintain in the HFT device via an upward force and/orfriction between the water chamber 8600 and the HFT device 8000. Thewater chamber 8600 can be inserted or removed without having tomanipulate (e.g. press down) another feature, such as latch or bar.

The water chamber 8600 has a water chamber gas inlet and a water chambergas outlet 8604. The water chamber gas inlet can have a water chambergas inlet axis and the water chamber gas outlet 8604 can have a waterchamber gas outlet axis. The water chamber gas inlet axis and the waterchamber gas outlet axis may be parallel. Further, a plane drawn betweenthe water chamber gas inlet axis and the water chamber gas outlet axismay be parallel to a typical table, nightstand, or desk located in theuse environment, a platform 8910 on a cart 8900 or I.V. pole (e.g. pole8930) where the HFT device may be placed during use, or the bottom ofthe HFT device itself. The gas moves through the water chamber 8600picking up heat and/or humidity and then into the delivery circuit 8700.It is preferred that the humidified gas that exits either the waterchamber 8600 not enter into or through a portion of the HFT deviceitself to avoid risk of contamination or the need to clean or disinfectthat portion of the HFT device prior to use on another patient.

The water chamber 8600 can consist of a housing that is clear (e.g. madeof a resin such as polystyrene) that allows the operator to see thewater level inside. The water chamber 8600 can have a heat transferplate (e.g. made of metal such as aluminum). The heat transfer plate maybe bonded to the housing (e.g. UV cured adhesive). In an alternateembodiment, a gasket (e.g. an o-ring) may be used to couple and/or sealthe heat transfer plate to the housing. The water chamber 8600 may havean inlet baffle on the water chamber gas inlet to prevent water fromsplashing towards the outlet filter 8090. The water chamber 8600 mayhave an outlet baffle on the water chamber gas outlet 8604 to preventwater from splashing towards the delivery circuit 8700, for exampleduring movement or transportation of the HFT device.

The operator may fill the water chamber 8600 manually with water up to amaximum level, which may be indicated by markings on the water chamber8600. In a preferred embodiment, the water chamber 8600 may have anautomatic filling system to replace the otherwise manual process offilling the water chamber 8600 with water from a sterile water bag(e.g., water bag 8920) that is suspended above the HFT system. In amanual arrangement, the operator must attend to the device periodically,as needed, in order to verify that the water chamber 8600 is being keptat a water level that is adequate for the device to function normally.If the water level is too low, water must be added to the water chamber8600. The manual filling process usually involves the operatorphysically releasing a pinch valve (or other valve mechanism) thatnormally impedes water flow from the sterile water bag's tubing andwaiting a few moments for the water chamber 8600 to fill to the correctlevel before re-closing the valve. Maintaining a water level that isadequate for normal device function is necessary to prevent unwantedinterruptions to therapy. If the water chamber 8600 is allowed to reacha very low level or empty water level, the device may signal an audiblealert. If the low water condition is not addressed in time, the devicemay either continue to supply under-humidified respiratory gas or mayautomatically pause the gas delivery until the condition is resolved.The advantages of an automatic filling system is that it ensures anadequate water level (e.g. a continuous level, such as a predeterminedminimum level) in the water chamber 8600 until the water bag 8920 isempty and that it eliminates the need for operator involvement in theinterim. With the automatic filling system, when the water is releasedinto the water chamber 8600 from the water bag 8920, the water levelinside the water chamber 8600 will rise until a plastic float componentinside seals the fill port. As the water is consumed by the heatedhumidification process, the water level falls and the float lowers,allowing more water from the water bag 8920 to fill the water chamber8600 again until the port is re-sealed. If left unattended, this processwill continue until the water bag 8920 is completely empty.

The delivery circuit 8700 provides a conduit for the heated and/orhumidified respiratory gas as the gas is transported from the waterchamber 8600 to the patient interface. The delivery circuit 8700 mayhave a heating element inside, such as a heated wire 8740. The heatedwire 8740 may extend through some or all of the delivery circuit. Theheated wire 8740 may be straight, coiled like a spring, or embedded inthe delivery circuit 8700. The delivery circuit 8700 actively maintainsthe desired humidity and temperature parameters of the gas and preventsand/or minimizes rainout or excessive moisture condensation inside thedelivery circuit 8700. Rainout is a concern for the safety of thepatient.

The delivery circuit 8700 can have a first connector 8710, a secondconnector 8720, and a tube 8730 (e.g. a corrugated tube) there between.The first connector 8710 can connect the delivery circuit 8700 to thewater chamber 8600. FIG. 45 illustrates a perspective sectional view ofan embodiment of first connector end and the tube 8730 of the deliverycircuit 8700. The first connector 8710 may have a body that is rigid(e.g. rigid portion 8702) and provides structure, such as a plastic, andthat houses first connector electrical contacts 8712. The firstconnector electrical contacts 8712 may be integrally molded into thebody. Alternatively, the body may be flexible, have a flexible portion(e.g. by overmolding), or have a flexible portion (e.g. flexible portion8704) that is coupled with the rigid portion 8702. The first connector8710 (or its flexible portion) can facilitate sealing and/or couplingthe first connector 8710 with the water chamber 8600 (e.g., at waterchamber gas outlet 8604). The first connector (or its flexible portion)can facilitate coupling the delivery circuit 8700 to the enclosure ofthe HFT device. For example, the first connector 8710 (or its flexibleportion) conforms to a mating socket 8200 in the enclosure of the HFTdevice 8000 to provide a snug, secure mechanical engagement. FIG. 43illustrates mating socket 8200, contacts 8210, and sensor port 8220 ofHFT device 8000, as well as water chamber gas outlet 8604 of waterchamber 8600. FIG. 44 illustrates first connector 8710, first connectorcontacts 8712, first connector sensor port 8714, and first connectoro-ring of delivery circuit 8700. The delivery circuit 8700 may couplewith the HFT device 8000 or the water chamber 8600 via a friction fit.The first connector 8710 (through either the rigid portion or theflexible portion) can provide a hand-grip for the user to insert orremove the delivery circuit 8700 from the water chamber 8600 and/or theHFT device 8000.

The delivery circuit 8700 can also have a long, flexible sensing conduit(e.g., sensing conduit 8760) (and/or or a sampling conduit in otherembodiments) that is internal to the delivery circuit (i.e. routedthrough the annular flow path through the tube 8730). In an alternateembodiment, the sensing conduit 8760 may be external (but possiblycoupled) to the delivery circuit 8700. In another alternate embodiment,the tube 8730 could be a multiple lumen tube where a first lumen is thegas delivery path, a second lumen is the sensing conduit (or a samplingconduit), and possibly a third lumen is a sampling conduit. The sensingconduit 8760 (via a first connector sensor port 8714) can pneumaticallyconnect the HFT device (via a sensor port 8220 on its enclosure) to thedistal end of the patient interface (e.g. distal end of second conduit8820). The use of a sensing conduit (or sampling conduit) can allow allelectrical sensing components required for signal processing to remaininside the HFT device with the other electronics, rather than havingelectrical sensing components in one of the disposable components (e.g.on the distal end of the patient interface).

When the delivery circuit 8700 is coupled with the HFT device 8000, aseal can be created between the sensor port 8220 on the HFT device andthe first connector sensor port 8714 in the delivery circuit 8700. Thedelivery circuit or the HFT device may have a seal (e.g. first connectoro-ring 8716) to facilitate this seal. When the delivery circuit iscoupled with the enclosure of HFT device, the first connector contacts8712 on the delivery circuit can engage with contacts 8210 on the HFTdevice 8000. This electrical engagement can enable the control of thethermal components in the delivery circuit 8700 by the software of theHFT device to maintain the desired temperature and humidity parametersof the gas. The delivery circuit 8700 may also have at least twotemperature sensors (e.g. thermistors) internally. A first thermistor8742 can be located near the first connector 8710 and a secondthermistor 8744 can be located near the second connector 8720. Thethermistors can provide temperature feedback to the main PCB 8060 viathe electrical contact engagement between the delivery circuit 8700 andthe HFT device. The heated wire 8740 is powered by the HFT device viathe electrical contact engagement between the delivery circuit u and theHFT device.

FIG. 46 illustrates a first perspective sectional view of an embodimentof the second connector end of the delivery circuit 8700 and the patientfitting end of the patient interface. FIG. 47 illustrates a secondperspective sectional view of an embodiment of a second connector end ofthe delivery circuit 8700 and a patient fitting end of the patientinterface. FIG. 48 illustrates a perspective sectional view of anembodiment of the second connector end of the delivery circuit 8700 withthe second connector and the sensing conduit removed to show some of theinternal components. The delivery circuit 8700 can have a holder 8750internal and near the second connector 8720. The holder 8750 can couplewith the second thermistor 8744 and/or the heated wire 8740. The holder8750 can provide a means for pulling during assembly the secondthermistor 8744 and/or the heated wire 8740 through the delivery circuit8700 towards the second connector 8720. The holder 8750 can maintain aspecific distance between the heated wire 8740 and the second thermistor8744 to ensure that the gas temperature reading by the second thermistor8744 is not influenced or made inaccurate by the temperature of theheated wire 8740. The heated wire 8740 can bend or wrap around theholder 8750 to facilitate the return of the heated wire 8740 back to thefirst connector 8710. The holder 8750 can couple to the tube 8730, forexample by having a protrusion (i.e. a ring or partial ring) thatinserts into at least one of the corrugations on the tube 8730 or cancouple with the second connector 8720. The holder 8750 can provide ameans for positioning the holder 8750 at a specific location within thetube 8730 or a certain distance from the second connector 8720. Thesecond connector 8720 can have a port (e.g., second connector sensorport 8722) to connect the sensing conduit 8760.

The patient interface, such as patient interface 8800, may have a nasalcannula portion 8840 that is intended to enter the nasal passages. Thepatient interface 8800 may have a first conduit 8810 for delivering therespiratory gas. The patient interface 8800 may have a second conduit8820 for sensing or sampling (e.g. collecting pressure data in the nasalpassages via the nasal cannula portion 8840). As shown in FIG. 49, firstconduit 8810 and second conduit 8820 may extend through the nasalcannula portion 8840. In a preferred embodiment, patient interface 8800may have a two first conduits 8810, 8812 as shown in FIG. 49. In oneembodiment, patient interface 8800 may have a two second conduits 8820,8812 as shown in FIG. 49. The patient interface 8800 may mechanicallyand fluidly couple with the delivery circuit 8700 via a friction fit.The patient interface 8800 may have a patient fitting 8830 that maycouple with the second connector 8720 to allow for the delivery of therespiratory gas through patient fitting 8830 and to a first conduit(e.g. first conduits 8810, 8812) as shown in FIG. 47. When the patientinterface 8800 is coupled with the delivery circuit 8700, a seal can becreated between the sensing conduit 8760 (via second connector sensorport 8722) in the delivery circuit and a patient fitting sensing conduit8832 in the patient fitting as shown in FIG. 46. The patient fittingsensing conduit 8832 in the patient fitting pneumatically couples orcommunicates with a second conduit (e.g., second conduits 8820, 8822).Therefore, the second conduit can be in communication with the sensorport 8220 on the HFT device. The patient interface 8800 can be describedas a sensing-enabled nasal cannula patient interface. In one embodimentshown in FIG. 46, the fitting sensing conduit 8832 in the patientfitting 8830 can split into two fitting sensing conduits 8834, 8836which can pneumatically couple with two second conduits 8820, 8822. Asshown in FIG. 46 and FIG. 47, first conduit 8810 may have a larger borethan the bore of second conduit 8820. The nasal cannula portion 8840 andthe patient fitting 8830 can be connected by one or more patient tubes.A patient tube may be single or double lumen tube. A double lumenpatient tube may have a first lumen for gas delivery and a second lumenfor sensing or sampling.

The main PCB 8060 of the HFT device may have a sensor 8064 for takingmeasurements at or proximal the outlet of the patient interface. In oneembodiment, the sensor 8064 can be a pressure sensor for measuring theairway pressure of the user. In this embodiment, the delivery circuitand the patient interface can have a conduit system that communicateswith the pressure sensor. This would allow the HFT system to monitorand/or control pressure. In an alternate embodiment, the sensor 8064 canbe for sampling the gas at or proximal the outlet of the patientinterface. For example, the gas exhaled by the user may be sampled forCO₂ content. In a similar manner to the pressure sensor embodiment, thedelivery circuit and the patient interface would have a conduit systemthat communicates with the sensor 8064 for sampling.

Different versions of delivery circuit can couple with the HFT device.As mentioned throughout, a delivery circuit can have thermal,electrical, temperature sensing, pressure sensing, and/or gas samplingcapabilities and/or conduits in addition to its gas delivery function.The HFT device can be configured to recognize what type of deliverycircuit is being connected to the device. For example, when a deliverycircuit with gas delivery, electrical, and pressure sensing capabilitiesis connected, the HFT device could recognize this type of deliverycircuit and consequently activate the pressure sensing aspects of theHFT device, such as pressure sensing graphics, alarms, etc. Differentdelivery circuits with different capabilities then could serve toactivate different and various functionality of the HFT device, whichmay exist in the HFT device but be dormant or inactive depending on thedelivery circuit connected. The HFT device may have mechanical,electrical, or optical means for recognizing the delivery circuit typeconnected. In one embodiment, the delivery circuit may depress certainswitch on the HFT device or may contact certain electrical contacts onthe HFT device. In another embodiment, the HFT device may optically reada certain delivery circuit or may scan a feature (e.g. a barcode orserial number) on a certain delivery circuit. In one example, if anoperator tried to connect a delivery circuit not authorized orcompatible with the HFT device (e.g. a delivery circuit connected to asealed patient interface), the HFT device may be programmed to havelimited function or not function at all. In an alternate example, if anoperator tried to connect a delivery circuit connected to a sealedpatient interface, the HFT device may be programmed to switch to abi-level or Bi-PAP mode (e.g. pressure based mode) instead of an HFTmode (e.g. flow based mode) and actually allow use with a sealed masklike a CPAP, Bi-PAP, or a ventilator.

The disposable components, such as the outlet filter 8090, water chamber8600, delivery circuit 8700, and patient interface 8800, may beindividually removed from the HFT device system after use.Alternatively, groups of these disposable devices may be removed at thesame time. For example, the outlet filter may be decoupled from the HFTdevice in one motion to disengage the water chamber, delivery circuit,and patient interface at the same time. This is advantageous to simplifythe disassembly, as well as to minimize the amount of water or othercontents in the disposable components that may be inadvertently leakedinto the environment during disassembly.

The HFT device may further serve as a diagnostic device either duringits typical HFT use or while it not being used for typical HFTtreatment. The HFT device could utilize the previously mentioned sensingcapabilities (e.g. pressure sensing, gas sampling, etc.) for diagnosticapplications. For example, the HFT device may be used to diagnosisrespiratory alignments such as sleep apnea. The HFT device couldmonitor, measure, record, and output the necessary information. The HFTdevice could incorporate functionality or accessories to includedetermination of stage of sleep, for example via electroencephalogram(EEG), electro-oculogram (EOG), submental electromyogram (EMG) and/orelectrocardiogram/heart rate (ECG). The HFT device could incorporatefunctionality or accessories to include sleep parameters such asairflow, respiratory movement/effort, oxygen saturation (e.g. byoximetry), snoring, pulse rate, head movement, head position, limbmovement, actigraphy, and/or peripheral arterial tone. Diagnosticaccessories coupled with the HFT device could include a body sensors,pulse oximeter, a wearable wrist device, a chest or abdomen band orbelt, headgear, thermistor, nasal cannula, and/or nasal/oral oralcannula, any of these which may have integrated sensors or sensingtechnology.

The HFT device may receive information (e.g. software upgrades) via awired connection, USB, memory card, fiber optic, wireless connection,blue tooth, Wi-Fi, etc. The HFT device may send information (e.g.patient reports) via similar communication means. The HFT device mayinclude wired connection such as USB port 8066 or memory card, or awireless connection such as blue tooth or Wi-Fi.

The bulk of the work of heating the respiratory gas can be done by theheater 8052 (e.g. PTC heater element) that is part of the HFT device.This heater 8052 can be concealed by a heater plate 8050 (e.g. stainlesssteel material) of the HFT device, which may be in direct contact withthe base heat transfer plate (e.g. aluminum material) of the waterchamber 8600 during use. During the heating process, the duty cycle ofthe heater 8052 and/or the heated wire 8740 is precisely andcontinuously adjusted by the HFT device's embedded software in responseto feedback supplied by a temperature sensor 8054 that is located nearthe heater 8052 (and in some embodiments may be in contact with theheater plate 8050) and/or in response to the feedback supplied by thethermistors (e.g., first thermistor 8742, second thermistor 8744) in thedelivery circuit 8700.

The HFT device may periodically decrease the gas flow rate from the setgas flow rate to allow the lungs to temporarily return to a more normalresting volume. The HFT device may automatically lower the gas flow by acertain percentage or by a certain value from the set gas flow value fora specific amount of time over a certain frequency or time period. Forexample, the HFT device may automatically lower the gas flow by a 20% orby 5 L/min for five seconds every ten minutes. Alternatively, the HFTdevice may automatically adjust the gas flow by a certain percentage, bya certain value, or a certain multiple of the expected patient tidalvolume, for example based on age, weight, and/or BMI. For example, thegas flow may be decreased automatically by the HFT device to less thantwo times the patient expected tidal volume for five seconds everytwelve breathing cycles. These types of periodic deviations from set gasflow rates could be inputted by the operator via the GUI or may be partof the programmed software. In an alternate embodiment, the HFT systemmay be used as a bubble CPAP system. The patient interface may have anexpiratory tube connected to the nasal cannula portion for gas to exit.The distal end of the expiratory tube may be immersed in a water tank.In one embodiment, the water chamber may serve as the water tank. In analternate embodiment, the water chamber may have a first watercompartment that is fluidically coupled with the HFT device and thedelivery circuit and a second water compartment that is fluidicallycoupled with the expiratory tube only and serves as the water tank.Water is placed in the water tank. The depth to which the expiratorytube is immersed underwater can determine the pressure generated in theairway of the patient. The gas flow may flow through the expiratory tubeand bubble out into the water tank. The patient interface may be asealed interface. The pressure sensing technology of the HFT systemdescribed throughout can be used to verify that the patient is receivingthe desired pressure when the HFT system is being used as a bubble CPAPsystem or any embodiment described throughout. Automatic filling systemtechnology described previously could be applied to the water tank.

CONCLUSION

Many modifications and other embodiments of the inventions set forthherein will come to mind to one skilled in the art to which theseinventions pertain having the benefit of the teachings presented in theforegoing descriptions and the associated drawings. Therefore, it is tobe understood that the inventions are not to be limited to the specificembodiments disclosed and that modifications and other embodiments areintended to be included within the scope of the appended claims. Forexample, although the embodiment shown in FIG. 1 shows each nasal insert125, 130 having two inlets 152, 154, in alternative embodiments of theinvention, one or more of the nasal inserts 125, 130 may have more orless than two inlets (and/or more or less than two sensors). Further,sensors such as sensor 2120 may be situated or in communication with anyarea of the airway or with an artificial airway (such as that describedin Provisional Application Ser. No. 61/004,746 filed on Nov. 29, 2007;and is not limited to sensing the environment of the anterior nares.Although specific terms are employed herein, they are used in a genericand descriptive sense only and not for purposes of limitation.

What is claimed is:
 1. A high flow therapy system for delivering heatedand humidified respiratory gas to an airway of a patient, the systemcomprising: a respiratory gas flow pathway for delivering therespiratory gas to the airway of the patient by way of a non-sealingrespiratory interface; a housing; a blower contained within the housingto generate a flow of the pressurized respiratory gas; a heater plateconnected to the housing; a water chamber comprising (i) a basecomprising a heat transfer plate and (ii) a housing connected to thebase that, collectively, are configured to retain a volume of water,wherein the heat transfer plate of the water chamber is configured to beplaced in contact with and to receive a transfer of heat from the heaterplate, wherein heating of the heat transfer plate causes the volume ofwater to be warmed within the water chamber and for heat andhumidification to be added to the pressurized respiratory gas; tubingcomprising (i) a first connector that includes electrical contactsconfigured to be electrically connected to a mating socket on thehousing when the first connector is positioned to receive thepressurized respiratory gas with the added heat and humidification, (ii)a second connector that is configured to be fluidly connected to therespiratory gas flow pathway to deliver the pressurized respiratory gaswith the added heat and humidification to the patient via thenon-sealing respiratory interface, and (iii) one or more sensors thatare configured to generate sensor signals measuring one or morecharacteristics of the pressurized respiratory gas within the tubing; amicroprocessor contained within the housing that is configured to (i)receive the sensor signals from the one or more sensors of the tubingvia the mating socket and (ii) control operation of the blower and theheater plate based, at least in part, on the sensor signals, wherein themicroprocessor is configured to control a flow rate and the added heatand humidification of the pressurized respiratory gas via control of theblower and the heater plate.
 2. The high flow therapy system of claim 1,wherein the non-sealing respiratory interface comprises nasal cannula.3. The high flow therapy system of claim 1, wherein the one or moresensors are positioned internally within the tubing.
 4. The high flowtherapy system of claim 3, wherein the one or more sensors comprise afirst thermistor that is positioned within the first connector and thatis configured to measure a first temperature of the pressurizedrespiratory gas at the first connector.
 5. The high flow therapy systemof claim 4, wherein the one or more sensors further comprise a secondthermistor that is positioned within the second connector and that isconfigured to measure a second temperature of the pressurizedrespiratory gas at the second connector.
 6. The high flow therapy systemof claim 3, wherein the one or more sensors comprise a second thermistorthat is positioned within the second connector and that is configured tomeasure a second temperature of the pressurized respiratory gas at thesecond connector.
 7. The high flow therapy system of claim 1, whereinthe one or more sensors comprise one or more temperature sensorspositioned along a length of the tubing and configured to measure atemperature of the pressurized respiratory gas.
 8. The high flow therapysystem of claim 7, wherein the one or more sensors further comprise oneor more pressure sensors configured to measure a pressure of thepressurized respiratory gas.
 9. The high flow therapy system of claim 1,wherein the tubing further comprises a heated wire extending at leastpartially along a length of the tubing and that is configured to heatthe pressurized respiratory gas within the tubing, wherein themicroprocessor is further configured to control operation of the heatedwire with control signals delivered to heated wire via the electricalconnection between the electrical contacts and the mating socket. 10.The high flow therapy system of claim 9, wherein the microprocessor isconfigured to control the operation of the heated wire based, at leastin part, on the sensor signals.
 11. The high flow therapy system ofclaim 10, wherein the one or more sensors comprise one or moretemperature sensors within the tubing and sensor signals comprisetemperature measurements for the pressurized respiratory gas within thetubing.
 12. The high flow therapy system of claim 1, further comprising:receiving flanges positioned along the housing and adjacent the heaterplate that are configured to receive and position the water chamber ontop of the heater plate.
 13. The high flow therapy system of claim 12,wherein the receiving flanges are spring loaded to maintain contactbetween the heat transfer plate of the water chamber and the heaterplate.
 14. The high flow therapy system of claim 1, wherein the waterchamber further comprises a baffle positioned inside of the housing. 15.The high flow therapy system of claim 14, wherein the baffle comprisesan inlet baffle positioned on an inlet of the water chamber.
 16. Thehigh flow therapy system of claim 14, wherein the baffle comprises anoutlet baffle positioned on an outlet of the water chamber.
 17. The highflow therapy system 1, further comprising an oxygen inlet in the housingthat is configured to receive a flow of supplemental oxygen from anexternal source of oxygen, wherein the flow of supplemental oxygenreceived via the oxygen inlet is configured to be mixed with thepressurized respiratory gas prior to entering the water chamber.
 18. Thehigh flow therapy system of claim 1, wherein the microprocessor isfurther configured to control the blower and the heater plate to performa drying cycle.
 19. The high flow therapy system of claim 18, whereinthe drying cycle comprises at least the blower remaining active afteruse of the high flow therapy system to provide respiratory therapy tothe patient.
 20. The high flow therapy system of claim 19, whereindrying cycle further comprises pressurized gas being passed through thetubing and the non-sealing respiratory interface for a period of time ata higher temperature than the pressurized respiratory gas used toprovide the respiratory therapy to the patient.